Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hypoglycemia
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 succes...

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.

Tracking Information

NCT #
NCT04428866
Collaborators
University of Michigan
Investigators
Principal Investigator: Mary Elizabeth Patti, MD Joslin Diabetes Center