Mechanisms of Hypoglycemia in Patients Without Diabetes

Summary

The goal of this study is to identify physiologic and molecular mechanisms that underlie hypoglycemia in the absence of diabetes (or medications that can cause hypoglycemia) and to investigate potential genetic and microbiome differences which contribute to hypoglycemia. We will test the hypothesis that hypoglycemia in the absence of diabetes is linked to genetic variation or the microbiome, and identify whether additional medical history or diagnoses are enriched in the population of patients with hypoglycemia.

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.

Sponsors & Collaborators

• Joslin Diabetes Center

  lead OTHER

Principal Investigators

• Mary Elizabeth Patti, MD · Joslin Diabetes Center

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-11

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations