Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT04428866
Brief 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.
Detailed 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:
NCT04428866
Study Brief:
Protocol Section:
NCT04428866