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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 ...
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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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Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels
Rochester, MN
The purpose of the study is to determine whether a significant and predictable change in bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.
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An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Rochester, MN
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
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A Study to Test the Feasibility, Usability and Accuracy of a Smart Phone Food-Record App to Assess Dietary Intake in Patients Who Have Undergone Gastric Bypass Surgery
Rochester, MN
The purpose of this study is to assess the acceptability and accuracy of the smart phone food record App ‘HealthWatch 360’ in collecting food intake data from subjects. The nutritional analysis obtained will be compared with that of a 24 hour recall to assess accuracy.
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A Study to Evaluate Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Rochester, MN
The purpose of this study is to assess the effectiveness, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial hypoglycemia. Twelve eligible subjects will be randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research center (CRC) visits, followed by the other treatment at the second CRC visit. Subjects will be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week Outpatient Stage. A follow-up safety assessment visit will occur 14 to 28 days after a subject's last dose of study ...
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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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Feasibility of Use of BariCare App in Pre-bariatric Surgery.
Rochester, MN
This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.
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A Study of Surgical Management of Postprandial Hyperinsulinemic Hypoglycemia after Roux-en-Y Gastric Bypass Surgery
No Locations
The purpose of this study is to understand outcomes from patients who have undergone roux-en-y gastric bypass and developed postprandial hypoglycemia which required surgery.
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Hyperammonemia in Patients undergoing Roux-en-Y Gastric Bypass Surgery
Rochester, MN
The purpose of this study is to determine plasma levels of Peptide YY (PYY), ghrelin, ammonia, and amino acids prior to and after Roux-en-Y gastric bypass surgery.
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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.
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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.
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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.
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A Study to Determine the Effect of Endogenous Glucagon-Like Peptide-1 on Active Intestinal Glucose Transport and Intestinal Permeability
Rochester, MN
The purpose of this study is to determine the effect of endogenous glucagon-like peptide-1 on active intestinal glucose transport and on intestinal permeability.
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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.
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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.
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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 ...
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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.
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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.
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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.
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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.
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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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Observational Study of Wearable Health Monitoring Device
Rochester, MN
The purpose of this study is to assess if a larger interventional study is possible. This study will follow subjects wearing a small device that sticks to the skin temporarily to collect vitals information. This information is routed by 4G/5G wireless technology to a secured data system on the internet accessable by study team and funding sponsor personnel without any personally identifiable information for the assessment of connectivity, accuracy, and usefullness as compared to current health monitoring systems in clinical use both on-site at the hospital and at home.
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A StudyUsing Telemedicine Care to Determine What Bariatric Patients Prefer
Rochester, MN
The primary purpose of this study is to determine bariatric patients’ preference of telemedicine or in-person assessment for post-operative care.
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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 ...
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Comparison of the Diagnostic Accuracy of Fujifilm Endoscopic Hypoxia Imaging (FEHI) to Indocyanine Green Fluorescein Imaging in Assessing Intraoperative Tissue Ischemia in Gastrointestinl Surgery
Jacksonville, FL
The aims of this study are to compare the diagnostic accuracy of FEHI, a non-invasive, non-drug, spectral imaging technology to current standard of care, ICG fluorescein imaging, with regard to intraoperative tissue ischemia, to estimate the optimal threshold value for SpO2 in FEHI to achieve optimal correlation with ICG imaging, and to compare the time needed to complete FEHI compared to ICG. These will be compared in the final 70% of cases to avoid learning curve bias on the first cases.
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Pharmacogenomics and Post-Operative Nausea and Vomiting
Rochester, MN
The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. The hypothesis is that using genotypic variation in CYP2D6 to select the appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in the bariatric surgical population.
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Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
Rochester, MN
The investigators believe that the lessons learned from studies regarding 30-day and 90-day readmission are primarily due to failure of early symptom recognition, and medical error. Through the aid of remote monitoring and early symptom detection, the hypothesis for the current proposal is that interventions can be recommended in an earlier, remote fashion that may result in earlier post-surgical discharge, prevent decompensation, and prevent increased readmissions that have been associated with decreased LOS in other surgical populations.