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Mechanisms of Hypoglycemia in Patients Without Diabetes
Sponsor: Joslin Diabetes Center
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
33
Start Date
2020-08-11
Completion Date
2026-12
Last Updated
2026-02-06
Healthy Volunteers
Yes
Conditions
Interventions
Entry of demographic and medical history data into a deidentified database
Entry into repository for analysis.
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.
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.
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.
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.
activity monitor
The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear.
Locations (1)
Joslin Diabetes Center
Boston, Massachusetts, United States