Filter Results
Clinical Studies
Results filtered:Study status:
Open
Closed for Enrollment
Open
-
A Double-blind Randomized Placebo-controlled Dose-finding Phase II Study to Assess the Efficacy and Safety of Pasireotide s.c. in Patients with Post-Bariatric Hypoglycaemia (PASIPHY)
Rochester, Minn.
The purpose of this study is to evaluate the efficacy of pasireotide s.c. on level 2 hypoglycaemic events after a mixed meal tolerance test (MMTT) in patients with Post-Bariatric Hypoglycaemia (PBH) after 12 weeks of treatment.
-
Assessment of Extracellular Vesicle Cargo During Type 1 Diabetes Progression (AEVCDTDP)
Rochester, Minn.
This study aims to identify an early stage biomarker for type 1 diabetes. In vitro evidence identified a significant enrichment of the chemokine CXCL10 in β-cell derived EXO upon exposure to diabetogenic pro-inflammatory cytokines. The study also aims to test protocols for efficient isolation of plasma-derived EXO from small volumes of sample, develop an assay for the sensitive detection of CXCL10 in plasma-derived EXO, and characterization of plasma-derived EXO through assessment of concentration, size, and content (proteomics).
-
Correlation of Pancreatic Islet Morphology with Postprandial Glucose Tolerance in Subjects Undergoing Pancreatic Resection for Islet Cell Tumors
Rochester, Minn.
Determine the effect of endocrine pancreas morphology, turnover and dedifferentiation on glucose tolerance in humans.
-
Effect of glucagon on fasting insulin secretion and glucose metabolism in subjects without type 2 diabetes
Rochester, Minn.
The purpose of this study is to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.
-
Effect of insulin and insulin pulses on fasting glucagon secretion and on glucose metabolism in subjects without type 2 diabetes
Rochester, Minn.
The purpose of this study is to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.
-
Quantification of Insulin Synthesis and Secretion In Vivo (The purpose of this study is to quantify Insulin synthesis and secretion in vivo)
Rochester, Minn.
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.
-
Study to Evaluate the Effects of BKR-017 on Insulin Sensitivity and
Triglycerides in Type 1 Diabetes Subjects
Rochester, Minn.
This study will test the efficacy of BKR-017 (colon-targeted 500 mg butyrate tablets) on insulin sensitivity, glucose control and triglycerides in type-1 diabetes subjects.
-
The Effects of Glucagon on Hepatic Metabolism
Rochester, Minn.
The purpose of this study is to measure hepatic extraction of amino acid (AA) in response to physiologic post-prandial concentrations of glucagon. In addition to changes in essential AA, we will also measure the extraction of other AAs, and their metabolites, across the liver. While measuring the effect of glucagon on AA metabolism, we will also examine how EGP and hepatic lipid metabolism respond to these conditions. While early reports have focused on hepatic steatosis, we will ascertain if its presence is necessary to alter glucagon’s actions on hepatic
Closed for Enrollment
-
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Rochester, Minn.
The purpose of this study is to evaluate the role of GLP1R in the response to elevated glucagon concentrations.
The GLP-1 receptor gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. Results from this study may help us identify therapeutic pathways to prevent or reverse type 2 diabetes mellitus.
-
A Dose-response Study of the Effects of Exendin-9,39 on Gastrointestinal Symptoms and Food Intake
Rochester, Minn.
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 of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.
-
A Dose-Response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action
Rochester, Minn.
The purpose of the study is to examine the effect of different dosages of Exendin on glucose metabolism, glucagon and insulin secretion, and on insulin action.
-
A Dose-Response Study of the Effects of Ghrelin on Gastrointestinal Symptoms and Food Intake
Rochester, Minn.
The purpose of this study is to examine the effect of Ghrelin on the regulation of food intake and sensation of fullness after bariatric surgery.
-
A Multi-Center, Adaptive Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled (Sitagliptin), Parallel Group Study to Evaluate the Safety and Efficacy of TTP399 Following 6 Months Administration in Subjects with Type 2 Diabetes Mellitus on A Stable Dose of Metformin (AGATA)
Rochester, Minn.
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.
-
A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients with Dumping Syndrome
Rochester, Minn.
Multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome.
-
A Phase 2, Interventional, Randomized, Double-Blind, Placebo-Controlled Pilot Study of Glucagon RTU in Subjects Who Experience Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Rochester, Minn.
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 drug.
-
A Pilot Study Examining the Effect of Fasting Free Acid and Glucose Concentrations on Insulin Secretion
Rochester, Minn.
The purpose of this study is to determine if changes in fasting glucose and FFA concentrations alter 1st phase insulin secretion and proinsulin secretion in non-diabetic and pre-diabetic humans.
-
A Pilot Study to Quantify the Effect of Impaired Glucagon Suppression in Pre-diabetes
Rochester, Minn.
The purpose of this study is to determine the effect of impaired postprandial glucagon suppression on postprandial glucose metabolism.
-
A Pilot Study to Quantifying Insulin Synthesis and Secretion in Pre-diabetes
Rochester, Minn.
The purpose of this study is to determine the effect of diabetes-associated variation in TCF7L2 on insulin synthesis and on insulin secretion.
-
A Randomized, Active-Controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) versus Lantus in Patients with Type 1 Diabetes Mellitus
Rochester, Minn.
The purpose of this study is to demonstrate that a morning injection of Toujeo compared to Lantus will provide better glycemic control, as shown by Continuous Glucose Monitoring (CGM), in adult patients with type 1 diabetes mellitus.
-
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents (ENDO)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes.
-
A Randomized, Single Blind, Normal Condition-controlled, Two Period Crossover Study to Evaluate the Effect of Hyperoxia on Glucose Metabolism in Type 2 Diabetics
Rochester, Minn.
The purpose of this study is to evaluate if breathing pure oxygen overnight affects insulin sensitivity in participants with diabetes.
-
Adjustable Gastric Banding and Its Effects on Postprandial Glucose Metabolism Independent of Weight Loss
Rochester, Minn.
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.
-
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery (XOMA 358)
Rochester, Minn.
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
-
Counter-Regulation and Postprandial Symptoms after Meal Challenge in Patients who have Undergone Auto-Islet Transplantation
Rochester, Minn.
The purpose of this study is to determine the mechanism(s) underlying symptoms of hypoglycemia that are experienced by patients after auto-islet transplantation.
-
Direct Measurement of Proinsulin Clearance in Humans
Rochester, Minn.
The purpose of this study is to determine if changes in fasting glucose and FFA concentrations alter 1st phase insulin secretion and proinsulin secretion in non-diabetic and pre-diabetic humans after determining the proinsulin volume of distribution, clearance rate and half-life in humans.
-
Effect of Antecedent or Continuous Exendin-9,39 Infusion on Islet Function and Glucose Metabolism in Response to an Intravenous Glucose Challenge
Rochester, Minn.
The purpose of this study is to determine the effect of duration of exendin-9,39 infusion on insulin secretion.
-
Effect of Fasting Free Fatty Acids and Fasting Glucose on Postprandial Glucose Metabolism
Rochester, Minn.
The purpose of this study is to determine if changes in fasting glucose and fasting free fatty acids (FFA) concentrations alter postprandial glucose metabolism in non-diabetic and pre-diabetic humans.
-
Effect of Fasting, Endogenous GLP-1 Secretion on B-cell Response to Intravenous Glucose
Rochester, Minn.
The purpose of this study is to determine the effect of GLP-1 in priming β-cells for insulin secretion.
-
Effect of Genetic Variation in the GLP-1 Receptor on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetic Humans
Rochester, Minn.
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.
-
Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy
Rochester, Minn.
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 GLP-1 receptor agonist, to compare weight loss and CV risk factors.
-
Endogenous GLP-1 and Intestinal Permeability
Rochester, Minn.
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.
-
EPIDEMIOLOGY OF DIABETES INTERVENTIONS AND COMPLICATIONS (EDIC)
Rochester, Minn.
The purpose of this study is to use the well-characterized Diabetes Control and Complications Trial (DCCT) cohort of 1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes.
-
Exendin-9,39 and Satiety After Bariatric Surgery
Rochester, Minn.
The purpose of this study is to determine the effects of blocking the receptors of the Glucagon-like Peptide-1 (GLP-1) hormone after different types of bariatric surgery on the regulation of food intake and appetite control.
-
Genetic Risk Determinants in Families with High Penetrance Type 1 Diabetes
Rochester, Minn.
The purpose of this study is to identify novel genetic variants that predispose to Type 1 Diabetes.
-
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
Rochester, Minn.
The purpose of this study is to determine how amino acids alter the suppression of α-cell secretion by glucose.
-
Longitudinal Effects of Diabetes-Associated Variation in TCF7L2 on Glucagon and Insulin Secretion in Non-Diabetic Humans
Rochester, Minn.
The goal of this study is to determine the role of postprandial glucagon suppression and insulin secretion in the progression of glucose intolerance in people with diabetes-associated variation in TCF7L2.
-
Proinsulin and Glucagon Secretion in Postpartum Women with and without Gestational Diabetes
Rochester, Minn.
The purpose of this study is to determine the changes in tissue function that occur in the first year postpartum in women with and without gestational diabetes mellitus.
-
Relationship of the Glucose Threshold for Insulin Secretion with Beta-cell Function
Rochester, Minn.
The purpose of this study is to determine if the set-point for fasting insulin secretion, and the subsequent response to hyperglycemia, is altered in people with IFG with or without accompanying IGT.
-
Study of Residual Insulin (C-Peptide) Secretion (on EDIC Cohort)
Rochester, Minn.
The purpose of this study is to determine if you have the ability to secrete any measurable level of insulin. You will be asked to undergo a standard test called the Mixed Meal Tolerance Test (MMTT). The MMTT stimulates your body to secrete insulin. The C-peptide levels (amount of insulin that your body makes) will then be measured. A similar test was conducted when you were evaluated for enrollment into the DCCT. We want to see if that has changed some 25-30 years later.
-
The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Rochester, Minn.
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.
-
The Effect of Colesevelam Hydrochloride on Disposition Index and Incretin Concentrations in Subjects with Type 2 Diabetes Using a Double-Blind, Placebo-Controlled, Parallel-Group Study Design
Rochester, Minn.
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.
-
The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans
Rochester, Minn.
The experimental design we propose will enable the dissection of the relative contribution of insulin and glucagon concentrations to endogenous glucose production. Acquisition of this data will allow us to develop a model of insulin and glucagon contributions to postprandial glucose metabolism
-
The Effect of Vagal Nerve Stimulation on Enteroendocrine Secretion and Glucose Metabolism
Rochester, Minn.
The purpose of this study is to determine how common bariatric surgical procedures alter carbohydrate metabolism by examining the effect of vagal nerve stimulation on insulin secretion and action.
-
The Effects of Glucagon on Hepatic Metabolism in People with Type 2 Diabetes after Caloric Restriction (The Effects of Glucagon on Hepatic Metabolism in People with Type 2 Diabetes after Caloric Restricti)
Rochester, Minn.
The purpose of this study is to determine how caloric restriction alters hepatic glucagon action
Elevated fasting AA concentrations are associated with T2DM risk. In addition, hepatic steatosis has been associated with an impaired ability of glucagon to stimulate hepatic clearance of AAs. We and others have shown that caloric restriction lowers fasting glucose, EGP and glucagon. However, the effects on these parameters in the postprandial period are unclear. This study examine if prior observations can and to what degree, be explained by improved hepatic glucagon action. Because caloric restriction decreases hepatic fat content the experiment will also determine if a reduction in hepatic fat content is associated with changes in glucagon’s effects on hepatic AA, glucose, and lipid metabolism.
-
The Longitudinal Effect of TCF7L2 Genotype on a-cell and ß-cell Function
Rochester, Minn.
The purpose of this study is to determine the longitudinal effect of diabetes-associated variation in TCF7L2 on a-cell function and the contribution of a-cell function to longitudinal glucose tolerance and EGP in non-diabetic subjects.
-
To Determine the Effect of Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes
Rochester, Minn.
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.
-
Understanding the Interaction of Glucagon and Insulin Secretion to Determine Postprandial Glucose Concentrations in Prediabetes
Rochester, Minn.
The purpose of this study is to understand the effects of a hormone called glucagon in glucose metabolism in people with pre-diabetes.
.