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A Study of the Metabolome and Microbiome Following Bariatric Surgery, and the Effect on Metabolism in Patients with Type 2 Diabetes
Rochester, MN
The purpose of this study is to identify changes to the metabolome (range of chemicals produced in the body) and microbiome (intestine microbe environment) that are unique to Roux-en-Y gastric bypass surgery and assess the associated effect on the metabolism of patients with type 2 diabetes.
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A Study Assessing the Impact of a Whole Food Plant-Based Diet for Diabetic Patients Who are Undergoing a Total Joint Replacement
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the impact of a whole food plant-based diet on blood sugar control in diabetic patients versus a control group on the American Diabetics Association diet before having a total hip, knee, or shoulder replacement surgery.
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A Study of PDD in Type 2 Diabetes
Rochester, MN
The purpose of this study is to learn more about if the medication, Entresto, could help the function of the heart and kidneys.
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Stories for Change: Digital Storytelling for Diabetes Self-Management among Hispanic Adults
Rochester, MN
The purpose of this study is to evaluate the impact of a digital storytelling intervention derived through a community-based participatory research (CBPR) approach on type 2 diabetes mellitus (T2D) outcomes among Hispanic adults with poorly controlled type 2 diabetes mellitus (T2D) in primary care settings through a randomized clinical trial.
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Pharmacist Collaboration in the Care of Patients with Diabetes within the Primary Care Clinic Setting
Rochester, MN
The primary aim of this study is to compare the outcome measures of adult ECH type 2 diabetes patients who were referred to onsite pharmacist services for management of their diabetes to similar patients who were not referred for pharmacy service management of their diabetes. A secondary aim of the study is to assess the Kasson providers’ satisfaction level and estimated pharmacy service referral frequency to their patients. A tertiary aim of the study is to compare the hospitalization rates of type 2 diabetes rates who were referred to onsite pharmacist services for management of their diabetes to similar patients ...
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Family Centered Wellness Coaching Program in Patients at High Risk for Developing Diabetes
Rochester, MN
To explore the feasibility of conducting a family centered wellness coaching program for patients at high risk for developing diabetes, in a primary care setting.
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To determine engagement patterns.
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To describe characteristics of families who are likely to participate.
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To identify barriers/limitations to family centered wellness coaching.
To assess whether a family centered 8 week wellness coaching intervention for primary care patients at high risk for diabetes will improve self-care behaviors as measured by self-reported changes in physical activity level and food choices.
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Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effectiveness of Revita® DMR for improving HbA1c to ≤ 7% without the need of insulin in subjects with T2D compared to sham and to assess the effectiveness of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints.
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Metformin's Effect on Glucagon-induced Glucose Production and Protein Metabolism.
Rochester, MN
This study is being done to understand metformin's mechanisms of action regarding glucose production, protein metabolism, and mitochondrial function.
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Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
Rochester, MN
This study will evaluate whether bile acids are able to increase insulin sensitivity and enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance glycemic control. These observations will provide the preliminary data for proposing future therapeutic as well as further mechanistic studies of the role of bile acids in the control of glycemia in T2DM.
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Control-IQ Technology in Individuals with Type 2 Diabetes
Rochester, MN
The purpose of this study is to evaluate 6 weeks of home use of the Control-IQ automated insulin delivery system in individuals with type 2 diabetes.
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Development of Diabetes Mellitus Type 2 in Stress Hyperglycemia and Control of Known Diabetes Mellitus after Discharge
No Locations
The purpose of this study is to determine if Inpatient Stress Hyperglycemia is an indicator of future risk of developing type 2 Diabetes Mellitus.
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A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes
Rochester, MN
The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.
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Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes
Rochester, MN
The overall goal of this proposal is to determine the effects of acute hyperglycemia and its modulation by Glucagon-like Peptide-1 (GLP-1) on myocardial perfusion in type 2 diabetes (DM). This study plan utilizes myocardial contrast echocardiography (MCE) to explore a) the effects of acute hyperglycemia on myocardial perfusion and coronary flow reserve in individuals with and without DM; and b) the effects of GLP-1 on myocardial perfusion and coronary flow reserve during euglycemia and hyperglycemia in DM. The investigators will recruit individuals with and without DM matched for age, gender and degree of obesity. The investigators will measure myocardial perfusion ...
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Comparison of Bone Quality in Subjects with or without Type 2 Diabetes
Rochester, MN
The purpose of this study is to test the hypothesis that patients with T2DM will have greater deterioration in BMSi and in cortical porosity over 3 yrs as compared to sex- and age-matched non-diabetic controls; and identify the circulating hormonal (e.g., estradiol [E2], testosterone [T]) and biochemical (e.g., bone turnover markers, AGEs) determinants of changes in these key parameters of bone quality, and evaluate the possible relationship between existing diabetic complications and skeletal deterioration over time in the T2DM patients.
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Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes
Rochester, MN
The purpose of this study is to determine the effect of endogenous GLP-1 secretion on islet function in people with Typr 2 Diabetes Mellitus (T2DM).
GLP-1 is a hormone made by the body that promotes the production of insulin in response to eating. However, there is increasing evidence that this hormone might help support the body’s ability to produce insulin when diabetes develops.
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A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2
Rochester, MN
The purpose of this study is to assess whether psyllium is more effective in lowering fasting blood sugar and HbA1c, and to evaluate the effect of psyllium compared to wheat dextrin on the following laboratory markers: LDL-C, inflammatory markers such as ceramides and hsCRP, and branch chain amino acids which predict Diabetes Mellitus (DM).
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Stories for Change: Digital Storytelling for Diabetes Self-Management Among Somali Adults
Rochester, MN
The purpose of this study is to assess the effectiveness of a digital storytelling intervention derived through a community based participatory research (CBPR) approach on self-management of type 2 diabetes (T2D) among Somali adults.
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A Study of the Genetic Links of Type 2 Diabetes in Latino Families
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to find the inheritable changes in genetic makeup that are related to the development of type 2 diabetes in Latino families.
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Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes (REGENT-1-US)
Rochester, MN
The objective of this early feasibility study is to assess the feasibility and preliminary safety of the Endogenex Divice for endoscopic duodenal mucosal regeneration in patients with type 2 diabetes (T2D) inadequately controlled on 2-3 non-insulin glucose-lowering medications.
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A Study to Evaluate the Safety and Effectiveness of the Drug TTP399 to Target A1c in Type 2 Diabetics
Rochester, MN
This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active- controlled, parallel group, phase 2 study in subjects with Type 2 Diabetes Mellitus to evaluate the effect of TTP399 on HbA1c following administration for 6 months.
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An Imaging Study Measuring the Form and Structure of the Layers of the Duodenum in Patients with and without Type 2 Diabetes
Jacksonville, FL
This observational study is conducted to determine how the duodenal layer thicknesses (mucosa, submucosa, and muscularis) vary with several factors in patients with and without type 2 diabetes.
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Penile Length Restoration in Men with Type II Diabetes
Rochester, MN
The purpose of this study is to assess penile length pre- and post-completion of RestoreX® traction therapy compared to control groups (no treatment) among men with type II diabetes.
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The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application
Rochester, MN
This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" .
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A Study of the Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Rochester, MN
The purpose of this study is to determine the impact of patient decision aids compared to usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and use of resources in nonurban practices in the Midwestern United States.
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A Study to Evaluate the Effect of Hyperoxia on Glucose Metabolism in Type 2 Diabetics
Rochester, MN
The purpose of this study is to evaluate if breathing pure oxygen overnight affects insulin sensitivity in participants with diabetes.
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Natural History of Diabetes after Total Pancreatectomy
Rochester, MN
The purpose of this study is to estimate the risk of diabetes related complications after total pancreatectomy. We will contact long term survivors after total pancreatectomy to obtain data regarding diabetes related end organ complications.
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A Study of Nighttime Blood Sugar Control Patterns in Type 2 Diabetes
Rochester, MN
The purpose of this study is to understand nighttime glucose regulation in humans and find if the pattern is different in people with Type 2 diabetes
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The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Rochester, MN
The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
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Patient-Centered Exploration to Understand their perception of comprehensive regenerative care
Rochester, MN
The study purpose is to understand patients’ with the diagnosis of Diabetes Mellitus type 1 or 2 perception of the care they receive in the Diabetes clinic or Diabetes technology clinic at Mayo Clinic and to explore and to identify the healthcare system components patients consider important to be part of the comprehensive regenerative care in the clinical setting.
However, before we can implement structural changes or design interventions to promote comprehensive regenerative care in clinical practice, we first need to characterize those regenerative practices occurring today, patients expectations, perceptions and experiences about comprehensive regenerative care and determine the ...
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Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes
Rochester, MN
It is unknown how patient preferences and values impact the comparative effectiveness of second-line medications for Type 2 diabetes (T2D). The purpose of this study is to elicit patient preferences toward various treatment outcomes (e.g., hospitalization, kidney disease) using a participatory ranking exercise, use these rankings to generate individually weighted composite outcomes, and estimate patient-centered treatment effects of four different second-line T2D medications that reflect the patient's value for each outcome.
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Health and Wellness Coaching for Employees with T2D
Jacksonville, FL
The purpose of this mixed-methods study is to deploy the tenets of Health and Wellness Coaching (HWC) through a program called BeWell360 model, tailored to the needs of Healthcare Workers (HCWs) as patients living with poorly-controlled Type 2 Diabetes (T2D). The objective of this study is to pilot-test this novel, scalable, and sustainable BeWell360 model that is embedded and integrated as part of primary care for Mayo Clinic Employees within Mayo Clinic Florida who are identified as patients li)ving with poorly-controlled T2D.
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Effect of High Fat and High Glycemic Diets
Rochester, MN
The investigators will determine whether people with high muscle mitochondrial capacity produce higher amount of reactive oxygen species (ROS) on consuming high fat /high glycemic diet and thus exhibit elevated cellular oxidative damage. The investigators previously found that Asian Indian immigrants have high mitochondrial capacity in spite of severe insulin resistance. Somalians are another new immigrant population with rapidly increasing prevalence of diabetes. Both of these groups traditionally consume low caloric density diets, and the investigators hypothesize that when these groups are exposed to high-calorie Western diets, they exhibit increased oxidative stress, oxidative damage, and insulin resistance. The investigators will ...
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A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics
Rochester, MN
The purpose of this research is to find out how genetic variations in GLP1R, alters insulin secretion, in the fasting state and when blood sugars levels are elevated. Results from this study may help us identify therapies to prevent or reverse type 2 diabetes mellitus.
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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.
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A Study to Assess Bone Quality Characteristics, Comparing Type 2 Diabetes Patients who have or have not had Prior Fragile Bone Fractures
Rochester, MN
The purpose of this study is to assess key characteristics of bone quality, specifically material strength and porosity, in patients who have type 2 diabetes. These patients are at an unexplained increased risk for fractures and there is an urgent need to refine clinical assessment for this risk.
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A Study to Evaluate Diabetes Management Using Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events
Rochester, MN
Can QBSAfe be implemented in a clinical practice setting and improve quality of life, reduce treatment burden and hypoglycemia among older, complex patients with type 2 diabetes?
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A Study to Compare Perceived Diabetes Knowledge to Objective Diabetic Control Based on Hemoglobin A1c
La Crosse, WI
Questionnaire administered to diabetic patients in primary care practice (La Crosse Mayo Family Medicine Residency /Family Health Clinic) to assess patient’s diabetic knowledge. Retrospective chart review will also be done to assess objective diabetic control based on most recent hemoglobin A1c.
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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).
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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. ...
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Shared Decision Making with Diabetic Patients
Rochester, MN
This research study is being done to develop educational materials that will help patients and clinicians talk about diabetes treatment and management options.
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Dietary Interventions in Prediabetes
Rochester, MN
Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. Subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary intervention.
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Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Rochester, MN
To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.
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Pilot Study to Quantify Insulin Synthesis and Secretion In Vivo
Rochester, MN
The purpose of this study evaluates a subset of people with isolated Impaired Fasting Glucose with Normal Glucose Tolerance (i.e., IFG/NGT) believed to have normal β-cell function in response to a glucose challenge, suggesting that – at least in this subset of prediabetes – fasting glucose is regulated independently of glucose in the postprandial period. To some extent this is borne out by genetic association studies which have identified loci that affect fasting glucose but not glucose tolerance and vice-versa.
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A Study to Evaluate the Impact of Nutrition Education and Access to Nutritious Foods on Diabetes Control
Mankato, MN
The purpose of this study is to evaluate whether or not a 6 month supply (1 meal//day) of healthy food choices readily available in the patient's home and self management training including understanding of how foods impact diabetes, improved food choices and how to prepare those foods, improve glucose control. In addition, it will evaluate whether or not there will be lasting behavior change modification after the program.
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A Study to Evaluate the Effectiveness and Safety of Exenatide SR for Diabetes Prevention Following Kidney Transplantation
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare the rate of progression from prediabetes at 4 months to frank diabetes at 12 months (as defined by increase in HbA1C or fasting BS to diabetic range based on the ADA criteria) after transplantation in kidney transplant recipients on Exenatide SR + SOC vs. standard-of-care alone.
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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.
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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.
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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.
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Feasibility Study for a Web Based Health Coaching Program
Rochester, MN
This study is designed to compare an intensive lifestyle and activity coaching program ("Sessions") to usual care for diabetic patients who are sedentary. The question to be answered is whether the Sessions program improves clinical or patient centric outcomes. Recruitment is through invitiation only.
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A Study to Evaluate the Effect of Improving Glycemic Control on Gastric Emptying in Type 1 and Type 2 Diabetes Mellitus
Rochester, MN
The purpose of this study is to evaluate the effects of improving glycemic control, and/or reducing glycemic variability on gastric emptying, intestinal barrier function, autonomic nerve functions, and epigenetic changes in subjects with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) who are switched to intensive insulin therapy as part of clinical practice.
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Shared Decision Making With Pharmaceutical Care
Rochester, MN
A research study to enhance clinical discussion between patients and pharmacists using a shared decision making tool for type 2 diabetes or usual care.
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Health Benefits of Pulsed Electromagnetic Field Therapy using Bioboosti
Scottsdale/Phoenix, AZ
While the potential clinical uses of pulsed electromagnetic field therapy (PEMF) are extensive, we are focusing on the potential benefits of PEMF on vascular health. We are targeting, the pre diabetic - metabolic syndrome population, a group with high prevalence in the American population. This population tends to be overweight, low fitness, high blood pressure, high triglycerides and borderline high blood glucose.
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A Study to Analyze the Performance of Cobas Pulse System Point of Care Test for Glucose Monitoring
Rochester, MN
This is a study to evaluate a new Point of Care test for blood glucose monitoring.
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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.
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A Study of the Effects of a Nocturnal Rise in Cortisol on Glucose Production in Type 2 Diabetes
Rochester, MN
The purpose of this study is to assess the effects of a nighttime rise in cortisol on the body's glucose production in type 2 diabetes.
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Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Diabetes
Rochester, MN
The goal of this study is to evaluate a new format for delivery of a culturally tailored digital storytelling intervention by incorporating a facilitated group discussion following the videos, for management of type II diabetes in Latino communities.
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Addressing Diabetes Together
Rochester, MN
Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.
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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.
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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.
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Podocyturia in Diabetes Mellitus Type 2 and Proteinuric Glomerulonephritides
Rochester, MN
The goal of this study is to evaluate the presence of podocytes (special cells in the kidney that prevent protein loss) in the urine in patients with diabetes or glomerulonephritis (inflammation in the kidneys). Loss of podocyte in the urine may be an earlier sign of kidney injury (before protein loss) and the goal of this study is to evaluate the association between protein in the urine and podocytes in the urine.
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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.
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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 ...
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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 ...
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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 ...
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A Study to Evaluate the Safety and Effectiveness of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetes Caused Paralysis of the Stomach
Rochester, MN
The purpose of this study is to evaluate the effects of multiple dose regimens of RM-131 on vomiting episodes, stomach emptying and stomach paralysis symptoms in patients with Type 1 and Type 2 diabetes and gastroparesis.
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A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
Rochester, MN
The purpose of this study is assess the feasibility, effectiveness, and acceptability of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to improve diabetes self-management among adults in Southeast Minnesota (SEMN) treated for servere hypoglycemia by the Mayo Clinic Ambulance Services (MCAS).
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Examination of the Pancreas in New-onset Diabetes
Rochester, MN
The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer
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A Study of Pancreatic Polypeptide Response in Patients with Diabetes Mellitus with and without Pancreatic Cancer
Rochester, MN
The purpose of this study is to determine if a blood test called "pancreatic polypeptide" can help distinguish between patients with diabetes mellitus with and without pancreatic cancer.
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A Study to Evaluate the Effectiveness and Safety of Brolucizumab vs. Aflibercept in Patients with Visual Impairment Due to Diabetic Macular Edema
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).
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Mediators of insulin resistance in women with a history of gestational diabetes mellitus
No Locations
Women with gestational diabetes mellitus (GDM) are likely to have insulin resistance that persists long after pregnancy, resulting in greater risk of developing type 2 diabetes mellitus (T2DM). The study will compare women with and without a previous diagnosis of GDM to determine if women with a history of GDM have abnormal fatty acid metabolism, specifically impaired adipose tissue lipolysis. The study will aim to determine whether women with a history of GDM have impaired pancreatic β-cell function. The study will determine whether women with a history of GDM have tissue specific defects in insulin action, and also identify the effect of a ...
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A Study to Evaluate Dynamic Positron Emission Tomography Imaging to Explain Macrophage Activation in Diabetic Gastroparesis
Rochester, MN
The purpose of this study is to demonstrate feasibility of dynamic 11C-ER176 PET imaging to identify macrophage-driven immune dysregulation in gastric muscle of patients with DG. Non-invasive quantitative assessment with PET can significantly add to our diagnostic armamentarium for patients with diabetic gastroenteropathy.
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Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
Rochester, MN
Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research ...
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Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease
Rochester, MN
The purpose of this study is to assess the safety and tolerability of intra-arterially delivered mesenchymal stem/stromal cells (MSC) to a single kidney in one of two fixed doses at two time points in patients with progressive diabetic kidney disease.
Diabetic kidney disease, also known as diabetic nephropathy, is the most common cause of chronic kidney disease and end-stage kidney failure requiring dialysis or kidney transplantation. Regenerative, cell-based therapy applying MSCs holds promise to delay the progression of kidney disease in individuals with diabetes mellitus. Our clinical trial will use MSCs processed from each study participant to test the ...
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A Study to Examine Diabetes Control and Patient Reported Outcomes Among Kidney Transplant Recipients with Type 2 Diabetes
Rochester, MN
This study aims to measure the percentage of time spent in hyperglycemia in patients on insulin therapy and evaluate diabetes related patient reported outcomes in kidney transplant recipients with type 2 diabetes. It also aimes to evaluate immunosuppression related patient reported outcomes in kidney transplant recipients with type 2 diabetes.
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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.
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A Study to Evaluate How Semaglutide Works Compared to Placebo in People with Type 2 Diabetes and Chronic Kidney Disease
Rochester, MN
The purpose of this study is to evaluate whether or not semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will receive semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when ...
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Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)
Rochester, MN
The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Effectiveness of Nimacimab in Patients With Diabetic Gastroparesis
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and exploratory effectiveness of nimacimab in patients with diabetic gastroparesis.
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A Study to Evaluate the Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
Rochester, MN
The purpose of this study is to understand why patients with indigestion, with or without diabetes, have gastrointestinal symptoms and, in particular, to understand where the symptoms are related to increased sensitivity to nutrients.Subsequently, look at the effects of Ondansetron on these patients' symptoms.
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A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
Eau Claire, WI; Rochester, MN; Mankato, MN; La Crosse, WI
The purpose of this study is to prospectively assemble a cohort of subjects >50 and ≤85 years of age with New-onset Diabetes (NOD):
- Estimate the probability of pancreatic ductal adenocarcinoma (PDAC) in the NOD Cohort;
- Establish a biobank of clinically annotated biospecimens including a reference set of biospecimens from pre-symptomatic PDAC and control new-onset type 2 diabetes mellitus (DM) subjects;
- Facilitate validation of emerging tests for identifying NOD subjects at high risk for having PDAC using the reference set; and
- Provide a platform for development of an interventional protocol for early detection of sporadic PDAC ...
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A Study to Evaluate the Therapeutic Effectiveness of Rifaximin in Diabetic Gastroparesis Patients Using Bloating as the Primary Endpoint
Jacksonville, FL
The primary purpose of this study is to prospectively assess symptoms of bloating (severity, prevalence) in patients with diabetic gastroparesis.
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Treatment burden, stress, and coping in the context of social distancing: A qualitative study of patients with diabetes mellitus
Rochester, MN
The purpose of this study is to track the treatment burden experienced by patients living with Type 2 Diabetes Mellitus (T2DM) experience as they work to manage their illness in the context of social distancing measures.
To promote social distancing during the COVID-19 pandemic, health care institutions around the world have rapidly expanded their use of telemedicine to replace in-office appointments where possible.1 For patients with diabetes, who spend considerable time and energy engaging with various components of the health care system,2,3 this unexpected and abrupt transition to virtual health care may signal significant changes to ...
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A Study to Evaluate the Performance of an Advanced Algorithm with CGM in Adults, Adolescents, and Pediatrics
Rochester, MN
The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
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Dapagliflozin in Type 2 Diabetes or Pre-diabetes, and PRESERVED Ejection Fraction Heart Failure
Rochester, MN
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure, disease specific biomarkers, symptoms, health status and quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure with preserved systolic function.
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A Study to Determine the Impact of Patient-Centered Education and the Use of Digital Photography for Evaluating Adherence with Routine Foot Care and Decrease the Occurrence and Severity of Foot Ulcerations in High-Risk Diabetic Foot Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to look at the relationship of patient-centered education, the Electronic Medical Record (patient portal) and the use of digital photography to improve the practice of routine foot care and reduce the number of foot ulcers/wounds in patients with diabetes.
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Evaluation of a Mixed Meal Test for Diagnosis and Characterization of Type 3c diabeTes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis
Rochester, MN
Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels. This is a frequent problem that is most commonly due to type 2 diabetes. However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas.
The goal of this study is to develop a test to distinguish these ...
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Pyridorin in Diabetic Nephropathy
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.
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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).
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A Study to Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
Jacksonville, FL
The purpose of this study is to evaluate the ability of appropriately-trained family physicians to screen for and identify Diabetic Retinopathy using retinal camera and, secondarily, to describe patients’ perception of the convenience and cost-effectiveness of retinal imaging.
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A Study of the Effect of Dapagliflozin on Symptoms and Biomarkers in Diabetes Patients with Heart Failure
Rochester, MN
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients who have type 2 diabetes and chronic heart failure with reduced systolic function.
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Continuous Glucose Monitor (CGM) Use in COVID-19 Patients
Jacksonville, FL
The purpose of this research is to determine if CGM (continuous glucose monitors) used in the hospital in patients with COVID-19 and diabetes treated with insulin will be as accurate as POC (point of care) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.
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Remote Patient Monitoring (RPM) on Emergency Room Visits, Hospitalizations, Hospital Contacts, and Patient Quality of Life
Jacksonville, FL
Hypothesis: We hypothesize that patients from the Family Medicine Department at Mayo Clinic Florida who participate in RPM will have significantly reduced emergency room visits, hospitalizations, and hospital contacts.
Aims, purpose, or objectives: In this study, we will compare the RPM group to a control group that does not receive RPM. The primary objective is to determine if there are significant group differences in emergency room visits, hospitalizations, outpatient primary care visits, outpatient specialty care visits, and hospital contacts (inbound patient portal messages and phone calls). The secondary objective is to determine if there are ...
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Fenofibrate for Prevention of DR Worsening
Rochester, MN
The purpose of this study is to evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening or center-involved diabetic macular edema (CI-DME) with vision loss through 4 years of follow-up in participants with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
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Study to Assess Painful Diabetic Peripheral Neuropathy After High-frequency Spinal Cord Stimulation
Rochester, MN
The purpose of this study is to assess painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation.
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Determinants of Diabetic Nephropathy in American Indians
Scottsdale/Phoenix, AZ
The purpose of this study is to examine the evolution of diabetic kindey injury over an extended period in a group of subjects who previously completed a clinical trial which assessed the ability of losartan to protect the kidney from injury in early diabetic kidney disease. We will also explore the relationship between diabetic kidney disease and other diabetes complications, including neuropathy and retinopathy.
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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.