Mechanisms of Post-Bariatric Hypoglycemia

Status Active, not recruiting

Clinical Trial Summary

Post-bariatric hypoglycemia (PBH) is an increasingly recognized syndrome that is incompletely understood. The purpose of this study is to increase our level of understanding by investigating mechanisms contributing to this condition. Participation in this study will take place over four visits, which will include the following: - Wearing of a continuous glucose monitoring device; - Providing a stool sample (collected at home); - Measuring glucose and hormone levels in response to a meal; - Measuring glucose and hormone levels in response to an injection of glucagon; - Measuring hormone levels while glucose levels are gradually lowered, and during a controlled period of a low glucose level (hypoglycemic clamp). Investigators will test the hypothesis that counterregulatory hormone responses are impaired in individuals with PBH, and that differences in the intestinal bacteria (microbiome) may contribute to this condition.

Clinical Trial Description

Bariatric surgery is increasingly recognized as a potent tool for the treatment of type 2 diabetes (T2D), yielding not only weight loss but also rapid improvements in glycemia allowing discontinuation of diabetes-related medication within days after surgery. However, along with this metabolic success comes an increased incidence of severe hypoglycemia (termed post-bariatric hypoglycemia; PBH) for a subset of individuals. The goal of these studies is to identify physiological and molecular mechanisms that underlie PBH, to determine whether these changes also contribute to surgery-induced improvements in glucose regulation (homeostasis), and to define potential new therapeutic interventions for PBH. Participation in this study will take place over four visits, which will include the following: - Detailed history, physical exam, and laboratory testing to determine study eligibility - Assessment of glucose patterns using a masked continuous glucose monitor; - Analysis of a stool sample (collected at home); - Measuring glucose and hormone levels in response to a meal; - Measuring glucose and hormone levels in response to an injection of glucagon; - Measuring hormone levels while glucose levels are gradually lowered, and during a controlled period of a low glucose level (hypoglycemic clamp). Investigators will test the hypothesis that counterregulatory hormone responses are impaired in individuals with PBH, and that differences in the intestinal bacteria (microbiome) and hormones produced in response to a meal may contribute to this condition. ;

Study Design

Related Conditions & MeSH terms

Hypoglycemia

Clinical Trial Details

NCT number	NCT04428866
Study type	Observational
Source	Joslin Diabetes Center
Contact
Status	Active, not recruiting
Phase
Start date	February 26, 2020
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03482154` - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Completed	`NCT03667053` - Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children	Phase 3
Active, not recruiting	`NCT03422471` - Hypoglycemia and Autonomic Nervous System Function- B2	N/A
Recruiting	`NCT05379686` - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes	N/A
Completed	`NCT05597605` - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects	N/A
Not yet recruiting	`NCT05990933` - Role of Adrenaline in in the Inflammatory Response in Diabetes	N/A
Withdrawn	`NCT03736083` - Introducing CGM at Type 1 Diabetes Diagnosis	N/A
Completed	`NCT02966275` - Post Bariatric Closed Loop Glucagon Trial	N/A
Not yet recruiting	`NCT02909881` - Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes	N/A
Withdrawn	`NCT02518022` - How to be Safe With Alcoholic Drinks in Diabetes	N/A
Completed	`NCT02213003` - Allogeneic Islet Cells Transplanted Onto the Omentum	Phase 1/Phase 2
Completed	`NCT01176656` - Hypoglycemia: Physician and Patient Perspectives	N/A
Completed	`NCT01147276` - Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes	Phase 4
Completed	`NCT00998374` - Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge	N/A
Terminated	`NCT01225159` - Tight Glycaemic Control During Cardiac Surgery	N/A
Completed	`NCT00373854` - Study of How Low Blood Sugar Affects the Way Blood Vessels Work	N/A
Completed	`NCT00285233` - Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes	Phase 1/Phase 2
Recruiting	`NCT05916131` - Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.	N/A
Terminated	`NCT04026750` - Insulin Tolerance Test Study in Patients With Type 1 Diabetes	Phase 1
Completed	`NCT05133765` - The SMART B Exercise Study :''The SMART Study''	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.