Mechanisms of Post-Bariatric Hypoglycemia

Active, not recruitingOBSERVATIONAL
Enrollment

105

Participants

Timeline

Start Date

February 26, 2020

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

Conditions
Hypoglycemia
Interventions
DIAGNOSTIC_TEST

Continuous Glucose Monitoring

A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed during visit 1 in blinded (masked) mode, and will be worn for 10 days. Data will be analyzed to determine patterns of glucose during both day and night intervals.

DIAGNOSTIC_TEST

activity monitor

The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days to assess activity, concurrent with CGM sensor wear.

DIAGNOSTIC_TEST

Mixed meal tolerance test

After an overnight fast, participants will be given a standard liquid mixed meal; blood samples will be collected at baseline (fasting) and at defined time points after a meal for metabolic and hormonal analyses.

DIAGNOSTIC_TEST

Glucagon Sensitivity Testing

After baseline blood sampling, glucagon will be administered by injection, and blood samples will be collected for analysis of glucose and hormone responses. This will allow us to assess whether sensitivity to glucagon is altered in PBH.

DIAGNOSTIC_TEST

Hypoglycemic Hyperinsulinemic Clamp

This test will assess hormonal responses to hypoglycemia. Participants will arrive after an overnight fast. After baseline blood sampling, an infusion of insulin and glucose will be started, and infusions will be adjusted to allow glucose levels to drop very gradually. Blood samples will be collected for measurement of hormonal responses to lowering of glucose. This test will allow us to determine whether secretion of hormones which counteract hypoglycemia (counterregulatory hormones) is reduced in patients with PBH as compared with other groups.

DIAGNOSTIC_TEST

analysis of fecal microbiome

Participants will be asked to provide a fecal sample, collected at home, which will be analyzed to determine the types of bacteria present in the feces.

Trial Locations (1)

02215

Joslin Diabetes Center, Boston

All Listed Sponsors
collaborator

University of Michigan

OTHER

lead

Joslin Diabetes Center

OTHER