Mechanisms of Hypoglycemia in Patients Without Diabetes

Active, not recruitingOBSERVATIONAL
Enrollment

33

Participants

Timeline

Start Date

August 11, 2020

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Hypoglycemia
Interventions
OTHER

Entry of demographic and medical history data into a deidentified database

Entry into repository for analysis.

GENETIC

Blood sample for DNA analysis

Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing participants with hypoglycemia (both surgical and non-surgical) and healthy controls.

DIAGNOSTIC_TEST

Stool sample for microbiome analysis

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.

DIAGNOSTIC_TEST

Mixed meal tolerance test

For a subset of participants: 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

Continuous glucose monitoring

A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed 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.

Trial Locations (1)

02215

Joslin Diabetes Center, Boston

All Listed Sponsors
lead

Joslin Diabetes Center

OTHER