NCT04428723

Mechanisms of Hypoglycemia in Patients Without Diabetes

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Although there are several conditions which have been identified that cause, or contribute to hypoglycemia, diagnosis can be challenging, as the physiologic, and molecular mechanisms are incompletely understood. Additionally, treatment options are relatively limited, and often incompletely effective and/or not well tolerated. Investigating the causative factors and mechanisms of hypoglycemia is important therefore in improving our understanding in order to develop new and more effective approaches to treatment. The current study aims to: 1. more fully characterize clinical history and demographics in patients with diverse forms of hypoglycemia by creating and analyzing a patient database; 2. for a subset of patients, characterize metabolic and hormonal responses to a standard meal; 3. analyze DNA variants in individuals with hypoglycemia; 4. analyze differences in the intestinal microbiome in individuals with hypoglycemia.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-11
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-06-11
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States