Obesity

Displaying 129 studies

  • Using Wearable Technology to Increase Daily Activity: A Weight and Wellness Program Initiative Scottsdale/Phoenix, AZ

    The purpose of this project is to complete a chart review/ secondary data analysis during the first 6-month program period utilizing data from the 4291 PARTENHEIMER Obesity Registry and interval participant data from the Mayo360 Personalized Support System (Mayo360PSP) questionnaire to examine motivation and behavioral changes in program participants.

  • A Study to Evaluate the Experiences of Women with High BMI Status in Reproductive Care Jacksonville, FL; Rochester, MN

    The purpose of this research is to assess the experiences of women with high BMI status in accessing and receiving reproductive care which may include services offered and/or denied and prerequisites for treatment, such as weight loss, and to evaluate the effects of social and clinical weight bias and stigma on women with high BMI status in receiving reproductive care.

     

     

  • Quality of Life after Endoscopic Bariatric Therapies Rochester, MN

    The purpose of this study is to investigate the change in quality of life after endoscopic bariatric therapies and to correlate the changes in quality of life with changes in weight after endoscopic bariatric Therapies (EBTs).

  • Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss Rochester, MN

    It is unknown whether the bile acid pathway reacts differently to weight loss resulting from Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction alone.

  • Quality Of Life after Simultaneous Sleeve Gastrectomy and Liver Transplantation Rochester, MN

    The aim of this study is to assess the quality of life among a sample of obese liver transplant recipients and compare it between those who underwent sleeve gastrectomy and those who did not.

  • A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers Rochester, MN

    The purpose of this research is to establish the normal range of diameter and distensibility of pylorus and the fasting and postprandial antro-pyloric motility in healthy male and female adults.

  • Regulation of Muscle Protein Phenotype in Humans with Obesity Scottsdale/Phoenix, AZ

    The purpose of this study is to determine the turnover rate of motor protein isoforms (myosin heavy chain, MHC)  and overall muscle protein in skeletal muscle of subjects with obesity and lean controls in the basal state, and to determine stimulation of the turnover rate of motor protein (MHC isoforms) in skeletal muscle of subjects with obesity and lean controls by plasma amino acids and with and without prior exercise. 

     

     

  • Intragastric Balloon in Obese Adolescents With Comorbidities Rochester, MN

    The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.

  • Changes in Gut Microbiota After Placement of Endoscopic Intragastric Balloon Rochester, MN

    The primary aim is to study the correlation between changes in the gut microbiome of obese subjects undergoing an intragastric balloon procedure.

  • Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype Rochester, MN

    The purpose of this study is to evaluate the effect of IC-CBAS 1000 mg BID on EEC function, weight loss, satiety perception, and satiety GI hormones, in patients with APS-OB phenotype. A lifestyle intervention will be provided. These consist of an obesity physician consult, a low-calorie diet instructed by registered dietitians & nutritionists, and physical activity and behavioral suggestions. These interventions should last at least the length of the study. We will include otherwise healthy patients with a BMI > 30, age range 18-65 years, and APS-OB phenotype. Based on the results of our previous trial comparing weight loss in exenatide ...

  • ORBERA™ Post-Approval Study Rochester, MN

    A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA™ as an adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2

  • Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study No Locations

    This research study is being performed to find out if a new device, AspireAssist Aspiration Therapy System, can help people with obesity to lose weight without causing too many side effects.

  • Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study Rochester, MN

    The purpose of this study is to demonstrate that the safety of the device in the postmarket setting is comparable to what was observed in the US pivotal study and to more accurately determine the rates of certain serious adverse events so that this information can be used to inform patient labeling.

    Subjects in the open label, multi-center study will receive dietary/exercise counseling plus the Spatz3 Adjustable Balloon System for 32 weeks.

    Eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz3 Adjustable Balloon System for 32 weeks. All subjects ...

  • Weight and Wellness Solutions Registry Study Scottsdale/Phoenix, AZ

    The purpose of this study is to establish a registry database of patients that will be utilized for future research studies related to obesity, health, and weight management strategies.

  • A Study to See if Completing an Online Education Course Will Increase Weight Loss For Patients Scottsdale/Phoenix, AZ

    The purpose of this study is to test the effectiveness of an online education course for helping obese patients to reach and keep weight loss goals.

  • Utilization of Telehealth for Increasing Access to Bariatric Surgery. Jacksonville, FL

    The purpose of this study is is to assess the feasibility and acceptability of telehealth for increasing access to bariatric surgery and compare outcomes to patients who receive F2F visits.

  • Insulin Regulation of Lipolysis and Lipolysis Proteins Rochester, MN

    The purpose of this study is to determine whether impaired insulin-induced suppression of lipolysis (as measured by IC50) is related to lipolysis proteins in groups of volunteers known to vary widely with regards to abdominal adipocyte size and regulation of adipose tissue lipolysis, and whether the improved insulin regulation of lipolysis resulting from treatment with the PPARγ agonist pioglitazone, with or without weight loss, can be linked to specific changes in sets of PPARγ-responsive adipocyte lipolysis proteins in UBO adults.



     

     

     

     

     

  • A Study of Changes to the Microbe Environment in the Intestines of Obese People who Modify Their Diet and Lifestyle Rochester, MN

    The purpose of this study is to assess changes that occur in the intestine microbe environment of obese people as they perticipate in a structured diet and lifestyle modification.

  • Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity Rochester, MN

    Investigators are doing this research study to find out the effect of T6 dermatomal electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on appetite and weight loss.

  • A Study to Evaluate Peptamen in Obese Patients Rochester, MN

    The purpose of this study is to assess the effects of Peptamen Intense on body weight in tube-fed adults with obesity.

     

  • EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway Rochester, MN

    The purpose of this trial is to evaluate the proportion of obese patients who respond to setmelanotide at 52 weeks of treatment. The trial includes multiple independent sub-studies of setmelanotide in patients with obesity and at least one of 6 specific gene defects in the Melanocortin-4 Receptor pathway. 

  • A Study to See if Culturally Relevant Interventions Decrease Obesity in Hispanic Children Scottsdale/Phoenix, AZ

    The purpose of this study is to determine if culturally-relevant interventions will decrease obesity in underserved Hispanic children and help those children learn lifelong healthy habits.

  • A Study for the Treatment of Primary Obesity Rochester, MN

    The purpose of this study is to evaluate a treatment for obesity.

  • Social Support and Motivators for Adolescent Weight Loss Rochester, MN

    This study aims to examine associations of social support for healthful eating and physical activity with adolescents’ healthful and unhealthful weight management strategies and body mass index (BMI).  The study will compare motivators and level of motivation for adolescent weight loss between adolescents and parents and across care sites (i.e., primary care vs. specialty care for obesity). Finally, the study will examine the relations of adolescent- and parent-reported motivators and level of motivation for weight loss with adolescents’ healthful and unhealthful weight management strategies and BMI.

  • A Study to Evaluate the Effect of POSE2 on Long-term Gastric Motor Function Rochester, MN

    The purpose of this study is to explore the effectiveness and safety of a modified gastroplication technique for weight loss in five patients with obesity, and includes physiologic appraisal of gastric emptying (via gastric emptying breath test) and post-prandial gastric accommodation (via SPECT).

  • Changes in Gut Microbiota after Endoscopic Procedures for the Treatment of Obesity Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to learn more about the effects of similar weight loss through caloric restriction, gastric reduction, and bypass of the proximal small intestines on gut microbiota and compare them to changes in the microbiome of obese subjects undergoing sham procedures and life-style modification.

  • Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity Rochester, MN

    The purpose of this study is to provide the first integrated examination of the interaction between muscle insulin action and exercise-stimulated muscle glucose uptake in obesity from the whole body to the cellular/molecular level.

  • Dysfunction of Mesenchymal Stem/Stromal Cells Induced by Obesity Rochester, MN

    The purpose of this study is to determine how human obesity engages epigenetic mechanisms that impair human mesenchymal stem/stromal cells (MSC) mitochondrial structure and function and render MSC functionally deficient.  

  • A Study Comparing a Protective Ventilation Plan with Higher versus Lower Positive End Expiratory Pressure During General Anesthesia in Surgery for Obese Patients Rochester, MN

    The purpose of this study is to compare a ventilation strategy using higher levels of positive end expiratory pressure and recruitment maneuvers to one using lower levels of positive end expiratory pressure without recruitment maneuvers in obese patients at an intermediate-to-high risk for post surgery respiratory complications.

  • Physical Activity and Health Outcomes Rochester, MN

    Obesity is common in adults with complex medical problems with ensuing complications afterwards. Obese patients suffer higher mortality and impaired functional status often as a result of their obesity. One primary goal to reduce both obesity and improve functional status is exercise. The investigators hypothesize that a simple exercise intervention with limited behavioral goal-setting will reduce weight and increase functional status compared to usual care. As a secondary measure, the investigators hypothesize that using this intervention will reduce hospital admissions and ER visits.

  • Determining Lipid Content in Stool After Alpha-cyclodextrin No Locations

    The Investigator hypothesizes that the currently used dose of dietary ingredient alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared with placebo. The proposed studies will address the degree to which α-CD increases dietary fat loss. The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester, Minnesota.

  • Health Behaviors Among Hispanic and Somali Adults at Risk for Cardiovascular Disease Rochester, MN

    The purpose of this study is to conduct a social network analysis to identify peer interventionists and to assess existing social structures that contribute to obesity-related health behaviors among Somali and Hispanic immigrants. 

  • A Registry to Collect Data and Biospecimens from Patients who are Obese and are Candidates for Bariatric Surgery Jacksonville, FL

    The purpose of this study is to collect and maintain a clinical and pathology database, and a biobank of blood, stool, and tissue specimens, from patients being treated surgically for obesity. The hope is this will ultimately help identify biological predictors for matching the best bariatric surgery to the patient for maximizing the effectiveness of the weight loss.

  • Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients Rochester, MN

    Our overall goal is to determine the effect of Phentermine and Topiramate on gastric emptying, gastric accommodation, and satiety and satiation in obese participants.

  • A Study to Analyze the Effect of Obesity on Eosinophil (disease fighting white blood cell) Recruitment in Human Adipose Tissue Scottsdale/Phoenix, AZ

    To determine whether EOS recruitment in AT is impaired during obesity. Therefore, we hypothesize that chronic, low-grade inflammation of AT initiates epigenetic modifications in EOS and/or in AT, thereby impairing the recruitment of eosinophils.

  • Obesity Treatment Outcomes in Cardiac Transplantation Patients Scottsdale/Phoenix, AZ

    The purpose of this study is to prospectively evaluate the safety and effectivenes of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing cardiac transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.

  • Characterization of Bile Acid Pathway in Obesity Rochester, MN

    It is unknown whether the bile acid pathway is altered in obesity. This study is designed to compare obesity and health to determine if the bile acid pathway differs depending on health state.

  • A Study Providing the Use of Under Desk Elliptical Devices for Promoting Physical Activity Among Employees Rochester, MN

    The purpose of this study is to determine if employees will use under desk foot pedal elliptical devices at their workstation to increase their level of physical activity.

  • Effect of 12-Week Vegetarian Diet Intervention on Inflammatory Status and Cardio-Metabolic Parameters Rochester, MN

    The purpose of this study is to determine if providing a vegetarian diet intervention to obese individuals over a twelve-week period can reduce chronic inflammation as well as improve cardio-metabolic parameters that are precursors to the co-morbidities associated with obesity.

  • A Study to Better Understand Why Patients Gain Weight After Undergoing Liver Transplantation Rochester, MN

    The purpose of this study is to understanding the mechanisms of weight gain in patients following liver transplantation, action, and indicate approaches to prevent weight gain.

  • A Study to Evaluate the Effectiveness of a Healthy Living Weight Loss Program in Obese Patients Undergoing Bariatric Endoscopy on Weight Loss Outcomes Rochester, MN

    The purpose of this study is to compare weight loss, improvement of comorbidities, improvement of lipid profile, blood sugar in patients undergoing endoscopic sleeve gastroplasty or intragastric balloon between patients who are in a weight loss program and those who are not.

  • InBody Validation Study Rochester, MN

    With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically ...

  • Evaluate Reliability of New Technology for Body Measurements using Infrared Technology and Biplane Imaging Using Mobile Devices Rochester, MN

    This research study is being done to evaluate the reliability and reproducibility of an infrared 3D scanner and an iPad app in measuring body measurements in participants.

  • A Study of How the Natural Bacteria of the Intestines Can Affect Weight Loss Success Rochester, MN

    The purpose of this study is to find out how the naturally occurring bacteria (the microbiome) in your gut can affect your body weight

  • A Study of Time Restricted Eating in Obese Adults Rochester, MN

    The purpose of this study is to evaluate the effectiveness of early time-restricted eating versus, late time restricted eating, and daily caloric restriction alone for obesity, in addition to measure difference in A1c, fasting glucose, and lipid panels. Additionally, we hope to assess barriers to compliance and effect on quality of life.

     

  • A Study Comparing the Fatty Acids and Inflammation in Obese Vegetarians and Non-vegetarians No Locations

    The purpose of this study is to learn if eating a vegetarian diet changes the make up of a person's fatty acids as well as their levels of inflammation.

  • Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30 Jacksonville, FL

    The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.

  • A Study to Understand the Relationship Between Inflammation and Insulin Resistance in Adipose Tissue Scottsdale/Phoenix, AZ

    This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue .

  • Early Feasibility of Endoscopic Gastric Mucosal Ablation (GMA) as a Primary Obesity Therapy Jacksonville, FL

    The purpose of this study is to assess the feasibility of ablation of up to 70% of the gastric mucosa using HybridAPC to induce weight loss.  

  • DAYBREAK: Phase 2 Study in Patients With Specific Gene Defects in the MC4R Pathway Rochester, MN

    To evaluate the proportion of obese patients with genetic defects in the melanocortin-4 receptor (MC4R) pathway who achieve a clinically meaningful reduction in body weight in response to setmelanotide after an initial response to open-label treatment

  • Evaluate Reliability of New Technology for Body Measurements using Infrared Technology and Biplane Imaging Using Mobile Devices Rochester, MN

    This research study is being done to evaluate the reliability and reproducibility of an infrared 3D scanner and an iPad app in measuring body measurements in participants.

  • A Study of How the Natural Bacteria of the Intestines Can Affect Weight Loss Success Rochester, MN

    The purpose of this study is to find out how the naturally occurring bacteria (the microbiome) in your gut can affect your body weight

  • A Study of Time Restricted Eating in Obese Adults Rochester, MN

    The purpose of this study is to evaluate the effectiveness of early time-restricted eating versus, late time restricted eating, and daily caloric restriction alone for obesity, in addition to measure difference in A1c, fasting glucose, and lipid panels. Additionally, we hope to assess barriers to compliance and effect on quality of life.

     

  • A Study Comparing the Fatty Acids and Inflammation in Obese Vegetarians and Non-vegetarians No Locations

    The purpose of this study is to learn if eating a vegetarian diet changes the make up of a person's fatty acids as well as their levels of inflammation.

  • Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30 Jacksonville, FL

    The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.

  • DAYBREAK: Phase 2 Study in Patients With Specific Gene Defects in the MC4R Pathway Rochester, MN

    To evaluate the proportion of obese patients with genetic defects in the melanocortin-4 receptor (MC4R) pathway who achieve a clinically meaningful reduction in body weight in response to setmelanotide after an initial response to open-label treatment

  • A Study to Understand the Relationship Between Inflammation and Insulin Resistance in Adipose Tissue Scottsdale/Phoenix, AZ

    This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue .

  • Early Feasibility of Endoscopic Gastric Mucosal Ablation (GMA) as a Primary Obesity Therapy Jacksonville, FL

    The purpose of this study is to assess the feasibility of ablation of up to 70% of the gastric mucosa using HybridAPC to induce weight loss.  

  • A Study to Test the Safety and Effectiveness of the Spatz3 Adjustable Balloon System to Help Obese People Lose Weight Rochester, MN

    The purpose of this study is to evaluate the safety and effectiveness of the Spatz3 in subjects with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight control program.

  • Leptin Biology in Adipose Tissue Rochester, MN

    Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are high in obese subjects indicating resistance to the actions of leptin. High leptin levels have been associated with increased cardiovascular and metabolic risks, but it is not clear if increased leptin or leptin resistance contributes to the increased cardiovascular risk. Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue functions are not completely investigated in humans. Based on preliminary data the investigators hypothesize that resistance to leptin action in obese adipose tissue is responsible for altering the expression of ...

  • Weight Gain and Adipose Tissue Rochester, MN

    This study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease. Proinflammatory cytokines contribute to the initial influx of immune cells into adipose tissue during weight gain. However, mechanisms regulating these cytokines in the adipose tissue milieu and the effects of weight gain on adipose tissue are not completely understood.

    The study proposes to investigate ...

  • Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management Rochester, MN

    Currently in the United States about 97 million adults are considered obese, accounting for about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as a body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia® Zerona™ 2.0 Laser (which will be used in this study) has been approved by the FDA (K123237) as a non-invasive dermatological aesthetic treatment which can be used by individuals intending to reduce circumference of hips, waist, and thighs. Lorcaserin is ...

  • Multi-center Biobank and Outcomes Registry for Obesity La Crosse, WI; Rochester, MN; Jacksonville, FL

    The purpose of this study is to establish a multi-center biobank and outcomes registry of at least 2000 patients with obesity that allows for a better understanding of demographic, clinical, and biological variables that predict the severity of the disease, the development of weight-related complications, and the weight loss and weight-related complications outcomes in response to obesity interventions. 

  • Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy Rochester, MN

    Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a ...

  • Transition Metal Isotopic Analysis of Bariatric Surgery Patients Scottsdale/Phoenix, AZ

    The purpose of this study is to determine the isotopic composition of the transition metals Cu, Fe and Zn after bariatric surgery.

  • A Study of Successfully Using Physical Activity Monitoring Devices on Mayo Clinic Patients Scottsdale/Phoenix, AZ

    The purpose of this study is to successfully use physical activity monitoring devices with patients in the LIVE IT weight loss program.

  • A Study to Evaluate Setmelanoitide to Treat Patients with Rare Genetic Disorders of Obesity Rochester, MN

    The purpose of this study is to explore the impact of Setmelanotide on obesity in patients with various specific rare genetic mutations.

  • A Study to Establish a Social Network in the Immigrant Community for Weight Loss Intervention Rochester, MN

    The multi-purpose of this study is to pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities, and to assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.

  • Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults Rochester, MN

    Body-weight based interval training (IT) performed 3 times per week will lead to reductions in abdominal adiposity and reduce overall body fat percentage in overweight and obese sedentary adults more effectively than moderate intensity continuous training (MICT). Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese adults.

  • A Study of Severe Combined Immunodeficiency Disorders Rochester, MN

    In this prospective natural history study, the aim is to identify variables contributing to best outcomes for hematopoietic cell tranplantation (HCT) or other treatment where applicable (enzyme replacement or gene therapy), which is life-saving therapy for children with SCID, leaky SCID, Omenn syndrome and reticular dysgenesis. 

  • A Study to Compare Enteroendocrine Cells Between Individuals with Obesity and Healthy Volunteers Rochester, MN

    The purpose of this study is comparison of enteroendocrine cells between individuals with obesity and health and storage of tissue samples for future research

  • A Study of Individualized Obesity Pharmacotherapy Based on Obesity Phenotypes Rochester, MN

    The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.

  • A Study to Evaluate Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes Rochester, MN

    The purpose of this study is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.

  • Comparing ESG to ESG with APC Rochester, MN

    The objectives of this study are to assess the safety and durability of combined hybrid APC and ESG compared to traditional ESG, and to assess weight loss and improvement in obesity-related co-morbidities in combined hybrid APC and ESG compared to ESG alone.

     

     

     

  • A Study of the Effectiveness of Behavior Therapy on Weight Loss with Bariatric Surgery Rochester, MN

    The purpose of this study is to assess the impact of participation in a standardized behavioral weight management program on the percentage of excess weight lost and also the psychosocial and medical outcomes after  gastric bypass surgery.

  • Endoscopic Gastric Reduction for Weight Management Rochester, MN

    The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves ...

  • Revision of RYGB For The Treatment Of Weight Regain Using the OverStitch Device Rochester, MN

    This study will review and analyze the literature regarding endoscopic revision of Roux-en-Y gastric bypass surgery for the treatment of weight regain using the OverStitch, a minimally invasive endoscopic device. This study will also include information about patients who underwent TORe as part of their clinical evaluation and treatment for weight regain by chart review.

  • Multi-center ESG Randomized Interventional Trial (MERIT-Trial) Rochester, MN

    Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endolumenally placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 8 locations in the United States will participate in this study. The ESG procedure has been performed clinically for 3 years in the United States. We are completing ...

  • Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center Rochester, MN

    Approximately one third of the children and adolescents in the United States are either overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic groups and households with low socioeconomic status and low parental education. The Alternative Learning Center (ALC) within Rochester School District 535 provides viable educational options for students who are experiencing difficulty in regular educational systems. A greater proportion of students at ALC are minorities, qualify for free and reduced lunch and receive special education services. These children are likely to have unique barriers to physical activity and healthy eating.

    Specific Aims:

    Aim 1: ...

  • Identifying Variants in MC4R Pathway-Associated Obesity With Novel Hyperphagia Questionnaires Rochester, MN

    The purpose of this study is to assess the ability of the hyperphagia questionnaires to identify children and young adults with early-onset obesity for genetic testing to identify variants in 36 genes of interest associated with MC4R pathway genetic obesity

  • A Study to Screen Infant Healthy Growth Assessment and Intervention with Home Visiting Rochester, MN

    The primary purpose of this study is to develop a screening system for factors that impact growth in infants within the newborn nursery, as well as a feeding assessment survey to be completed at well child visits during the first 12 months of life.

     

     

     

     

     

     

  • Long Term Extension Trial of Setmelanotide Rochester, MN

    The purpose of this extension study of up to an additional 2 years duration beyond the index trial for patients who have completed a previous study of setmelanotide for genetic obesity disorders upstream of the MC4 receptor in the melanocortin-leptin pathway. Since continued assessments of the safety and efficacy of setmelanotide are the same in this extension protocol regardless of the disease studied in the index protocol, all patients can be followed in this single extension protocol. Nevertheless, the analysis of each individual disease will be performed separately with the ability to combine data from the original index protocol and ...

  • A Study of Student Outcomes from a Fitness and Nutrition Education Program Rochester, MN

    The purpose of this study is to examine whether an education program, designed in partnership with teachers at Moreland Elementary School in West St. Paul and Mayo Clinic InSciEd Out scientists, is able to influence the behavior and health literacy of students. This information will be collected in surveys before and after the students are given the curriculum during the school day.

  • FIT-T Study Rochester, MN

    FIT is grounded in social cognitive, self-determination, and family systems theories and, as such, aims to promote healthy eating and movement habits by facilitating the development of parent-adolescent communication and problem-solving skills to support the adolescents’ and family’s pursuit of health behavior change goals.

  • Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents Rochester, MN

    Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents have a high prevalence of Vitamin D deficiency as well as evidence of endothelial dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with Vitamin D would lead to improvement in endothelial dysfunction.

  • A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake Rochester, MN

    Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence ...

  • A Study to Determine if Differences in the Microbe Environment of the Intestines Connects to the Effects of Obesity on Intestinal Stem Cells Rochester, MN

    New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The purpose of this study is to find how the microbe envntironment of the intestines in obesity influences the growth of intestinal stem cells, which could then trigger intestinal tumors.

  • Waist Circumference Measurement and Weight Changes Over Time for Assessment of Metabolic Syndrome in Overweight and Obese Children in an Outpatient Clinic Setting Rochester, MN

    The purpose of this study is to increase the measurement of BMI and WC in the overweight (BMI at or greater than the 85th percentile) and obese (BMI at or greater than 95th percentile) outpatient pediatric population ages 6-19 at Mayo Clinic Rochester and surrounding satellite clinics.  Educate providers and nursing staff on the importance and technique of measuring the WC in the overweight and obese outpatient pediatric population with at least a yearly WC  on every child with a BMI at or greater than the 85th percentile.  Determine the prevalence of various components of the metabolic syndrome (MS) including ...

  • Obesity and IBS as likely associated comorbidities Scottsdale/Phoenix, AZ

    This study will evaluate obesity as a comorbidity in a population of patients with irritable bowel syndrome (IBS), and assess this cohort for vitamin D-deficiency. It will also determine whether alterations in the fecal microbiome and metaproteome, associated with vitamin D deficiency or other factors, underpin obesity-IBS comorbidity.

  • Healthy Immigrant Community: Mobilizing the Power of Social Networks Rochester, MN

    The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast MN.

  • Ultrasound Guided vs Unguided Intra-articular Knee Injections Rochester, MN

    To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion.

  • Molecular Regulation of Muscle Glucose Metabolism Scottsdale/Phoenix, AZ

    This protocol is being conducted to determine the mechanisms responsible for insulin resistance, obesity and type 2 diabetes.

  • Obesity Treatment Outcomes in Liver Transplant Recipients Scottsdale/Phoenix, AZ

    The purpose of this study is to prospectively evaluate the safety and effectiveness of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing liver transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.

  • Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Rochester, MN

    The purpose of this research is to find out if an aggressive intervention to lose weight, will improve symptoms in patients with obesity-related cardiomyopathy, which is also known as the obese phenotype of heart failure with preserved ejection fraction (HFpEF).

     

  • Perioperative Ketamine for Pain With Gastric Bypass Scottsdale/Phoenix, AZ

    Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea. Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients. This study is being done to find out ...

  • Interviews Assessing Mood and Eating Behavior Among Participants in the Sleep Restriction and Obesity Study IRB 11-007272 Rochester, MN

    The purpose of the study is to conduct qualitative interviews of participants in a sleep restriction study who were allowed free snacking to learn about their self-observations regarding their eating motivations and behaviors.

  • A Study to Evaluate Attitudes Toward Weight Loss in Sleep Apnea Rochester, MN

    The purpose of this study is to elicit detailed information from patients diagnosed with a sleep-related breathing disorder with severe obesity and sleep medicine providers regarding attitudes toward and acceptance of a multicomponent weight loss intervention based in health coaching. We anticipate that gaining a deeper understanding of attitudes toward weight loss in this population will provide insight into what may be feasible and acceptable aspects of a weight loss intervention. This information will then help guide the development of a multicomponent weight loss intervention based in health coaching and aimed at decreasing disease burden, increasing PAP adherence, and improving ...

  • Investigating if Rapid Gastric Emptying Predicts Future Weight Gain Rochester, MN

    The purpose of this study is to determine through a retrospective cohort if rapid gastric emptying is not only associated with obesity, but if it predicts the future development of the disease.

  • A Study to Evaluate Molecular Mechanisms of Exercise Benefits in Insulin Resistant People Rochester, MN

    The aim of the study is to investigate the effects of a 3-month resistance exercise program (in people aged 50 to 75) on muscle mass, body composition, muscle strength, brain function and cognition, muscle efficiency processing blood sugar, the body’s ability to build muscle, and fat cells.

    Earlier research has shown that exercise has significant benefits in preventing certain diseases and conditions such as diabetes, dementia, heart disease, and more. We also know from other research that resistance exercise (lifting weights) and aerobic exercise (running, biking, walking), improve metabolism through separate ways on the molecular level, also called “molecular pathways.” With ...

  • A Study to Evaluate Interactions Between Hormones and the Nervous System Rochester, MN

    The purpose of this study is to test the hypothesis that obesity is associated with impairment of cardiovascular reflex control, and that this impairment is linked to deficient leptin activity.

  • Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese Scottsdale/Phoenix, AZ; Rochester, MN

    To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes.

  • Sleep Restriction and Obesity Rochester, MN

    Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators hypothesize that sleep restriction will result in increased energy balance.

  • A Study to Evaluate Molecular Mechanisms of Exercise Benefits in Insulin Resistant People Rochester, MN

    The aim of the study is to investigate the effects of a 3-month resistance exercise program (in people aged 50 to 75) on muscle mass, body composition, muscle strength, brain function and cognition, muscle efficiency processing blood sugar, the body’s ability to build muscle, and fat cells.

    Earlier research has shown that exercise has significant benefits in preventing certain diseases and conditions such as diabetes, dementia, heart disease, and more. We also know from other research that resistance exercise (lifting weights) and aerobic exercise (running, biking, walking), improve metabolism through separate ways on the molecular level, also called “molecular pathways.” With ...

  • Gastric Epigenome and Transcriptome in Humans Rochester, MN

    The purpose of this study is to improve our understanding of why gastrointestinal symptoms occur in diabetes mellitus patients and identify new treatment(s) in the future.  

    These symptoms are often distressing and may impair glycemic control. We do not understand how diabetes mellitus affects the GI tracy. In 45 patients undergoing sleeve gastrectomy, we plan to compare the cellular composition of circulating peripheral mononuclear cells, stomach immune cells, and interstitial cells of Cajal in the stomach. 

     

  • Muscle Metabolism Characteristics Related to Diabetes-Related Conditions Rochester, MN

    Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM), whereas lower body obesity (LBO) is characterized by near-normal insulin sensitivity. It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking differs between different obesity phenotypes. Likewise, we do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. By measuring muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates we will provide the first integrated examination ...

  • Effects of Niacin on Intramyocellular Fatty Acid Trafficking in Upper Body Obesity and Type 2 Diabetes Mellitus Rochester, MN

    Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking is responsible for the abnormal response to insulin. Likewise, we do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. We will measure muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates under both saline control (high overnight FFA) and after an overnight infusion of intravenous ...

  • Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF Rochester, MN

    The purpose of this study is to evaluate the safety and tolerability of 134 days of daily dosing of HU6, to ealuate the effectiveness of HU6 on weight reduction, and  to evaluate the effect of HU6 treatment on exercise capacity.

  • Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome Jacksonville, FL

    Using stem cell derived intestinal epithelial cultures (enteroids) derived from obese (BMI> 30) patients and non-obese and metabolically normal patients (either post-bariatric surgery (BS) or BS-naïve with BMI < 25), dietary glucose absorption was measured. We identified that enteroids from obese patients were characterized by glucose hyper-absorption (~ 5 fold) compared to non-obese patients. Significant upregulation of major intestinal sugar transporters, including SGLT1, GLU2 and GLUT5 was responsible for hyper-absorptive phenotype and their pharmacologic inhibition significantly decreased glucose absorption. Importantly, we observed that enteroids from post-BS non-obese patients exhibited low dietary glucose absorption, indicating that altered glucose absorption ...

  • A Study Comparing the Effect of Niacin and Insulin on Splanchnic Bed Fatty Acid Spillover Rochester, MN

    The purpose of this study is to learn more about how the body stores dietary fat. Medical research has shown that fat stored in different parts of the body can affect the risk for diabetes, heart disease and other major health conditions.

  • A Study of Adjustable Gastric Banding and Its Effects on After Meal Glucose Metabolism, Independent of Weight Loss Rochester, MN

    The purpose of this study is to determine the mechanism(s) by which common bariatric surgical procedures alter carbohydrate metabolism. Understanding these mechanisms may ultimately lead to the development of new interventions for the prevention and treatment of type 2 diabetes and obesity.

  • A Study of the Effects of Inflammation on Fat Tissue and Insulin in People with Different Body Shapes No Locations

    The purpose of this study is to see why the ability of fat cells to respond to insulin is different depending on body shape and how fat tissue inflammation is involved.

  • A Study to Evaluate Using Pulsed Arterial Spin Labeling Magnetic Resonance Imaging (PASL-MRI) to Study the Function of the Hypothalamus in Anorexia and Obesity Rochester, MN

    The purpose of this study is to evaluate if pulsed arterial spin labeling magnetic resonance imaging (PASL MRI) is able to measure a difference in hypothalamic blood flow in patients with anorexia nervosa, opposite than obesity when compared to health.

  • Fat Biology, Sleep Disorders, and Cardiovascular Disease Rochester, MN

    Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to be a key process in the development of cardiovascular disease. Endothelial dysfunction appears to be caused by both sleep disordered breathing and obesity. As endothelial dysfunction is among the first clinical marker that predicts future cardiovascular events, understanding molecular mechanisms leading to impairment of endothelial function is very important. Endothelial function requires the proper functioning of endothelial nitric oxide synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal nitric oxide ...

  • Intramyocellular Fatty Acid Trafficking in Insulin Resistance States - Effects of Intestinal Delivery of Lipids Rochester, MN

    Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking is responsible for muscle insulin resistance, although it has been shown that raising FFA with Intralipid can cause muscle insulin resistance within 4 hours. We do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. We propose to alter the profile and concentrations of FFA of healthy, non-obese adults using an overnight, intra-duodenal palm oil infusion vs. ...

  • Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes Jacksonville, FL

    The objectives of this study are to identify circulating extracellular vesicle (EV)-derived protein and RNA signatures associated with Type 2 Diabetes (T2D), and to identify changes in circulating EV cargo in patients whose T2D resolves after sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB).

  • Addressing Diabetes Together Rochester, MN

    Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.

  • A Study to Evaluate the Combining of Endoscopic Ultrasound Guided Liver Biopsy and Stomach Balloon Placement for the Diagnosis and Management of Nonalcoholic Fatty Liver Disease and Obesity Rochester, MN

    The purpose of this study is to evaluate the usefulness of combining a core liver biopsy guided by endoscopic ultrasound and stomach balloon placement by endoscope for the diagnosis and treatment of fatty liver disease and obesity.

  • A Study of the Effect of Colesevelam on Glucose Metabolism in Patients with Type 2 Diabetes Rochester, MN

    The purpose of this study is to determine the metabolic effects of Colesevelam, particularly for the ability to lower blood sugar after a meal in type 2 diabetics, in order to develop a better understanding of it's potential role in the treatment of obesity.

  • A Study of the Relationship of Markers of Cellular Senescence to Skeletal Parameters in Type 2 Diabetes Mellitus Rochester, MN

    The purpose of this study is to test whether markers of cellular aging and the SASP are elevated in subjects with obesity and further increased in patients with obesity and Type 2 Diabetes Mellitus (T2DM) and to relate markers of cellular aging (senescence) and the SASP to skeletal parameters (DXA, HRpQCT, bone turnover markers) in each of these groups.

     

     

  • A Study of Effect of Different Biochemical Markers including Leptin and Spexin in Children Before and After Having Hypothalamus Surgery Rochester, MN

    The purpose of this study is to learn more about the changes in levels of Spexin, leptin and other biomarkers such as adiponectin and resting energy expenditure before and after hypothalamic surgery.

  • Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes Rochester, MN

    The purpose of this study is to look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. 

  • Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1 Scottsdale/Phoenix, AZ

    This study is being done to better understand the relationship between inflammation in your AT, abnormal deposition of fat around your liver and how this affects its appearance and function and ultimately insulin resistance.

  • A Study to Evaluate the Mechanisms Leading to Hyperoxaluria and Increased Risk of Kidney Stone Formation after Bariatric Surgery Rochester, MN

    This study aims to evaluate the mechanisms leading to hyperoxaluria and increased risk of kidney stone formation after bariatric surgery.

  • Breast Cancer WEight Loss Study (BWEL Study) La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take ...

  • A Study to See if There is a Connection Between Bad Childhood Experiences and Poor Blood Sugar Control in Patients with Type 1 Diabetes Rochester, MN

    The purpose of this study is to see if there is a connection between bad experiences in the patient's childhood, either by the patient or the parent, and poor blood sugar control, obesity, poor blood lipid levels, and depression in patients with type 1 diabetes.

  • A Study to Evaluate the Effectiveness and Safety of Aramchol Versus Placebo in Subjects With NASH (ARMOR) Rochester, MN

    The purpose of this study is to evaluate the effect of Aramchol as compared to placebo on NASH resolution, fibrosis improvement and clinical outcomes related to progression of liver disease (fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes).

     

     

  • Transforming Non-Invasive Liver Disease Detection by Magnetic Resonance Elastography Rochester, MN

    A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information ...

  • COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications Rochester, MN

    The purpose of this study is to determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19.

  • A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting Rochester, MN

    The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.

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