Hypoglycemia and the Gut Microbiome

Recruiting

• Conditions: Hypoglycemia

• Registration Number: NCT03385707
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

This study is designed to evaluate individuals who are currently experiencing symptoms of hypoglycemia, in order to discern correlations between microbiome composition and patterns of postprandial glycemia.

Detailed Description

Recent studies have shown that analysis of the gastrointestinal microbiome can be used to predict glycemic response to dietary intake. Specifically, integrative analysis of dietary consumption, anthropometrics, physical activity and gut microbiota composition can be used to predict postprandial glycemic excursions. The investigators hypothesize that individualized assessment of glycemic responses to food, together with analysis of the gut microbiome, will allow the design of a personalized dietary approach to minimize glycemic excursions for patients with post-bariatric and other forms of largely postprandial hypoglycemia. Identification of factors predictive of glycemic excursions and subsequent hypoglycemia may ultimately allow individuals to tailor their diet towards foods which would not induce hypersecretion of insulin and subsequent hypoglycemia.

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2019-02-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of cumulative duration of hypoglycemia	2 weeks	Duration of hypoglycemia will be assessed by: (1) the number of minutes per day with hypoglycemia, defined as sensor glucose \<70 mg/dl, and (2) the number of minutes per day of severe hypoglycemia, defined as sensor glucose \<55 mg/dl. Data will be captured for the entire 24 hour period as well as day and night subsets.

Secondary Outcome Measures

Name	Time	Method
Analysis of microbiome in individuals with post-bariatric hypoglycemia	2 weeks	Stool samples will be analyzed to determine microbiome community by 18S sequencing. Data will be integrated to determine relationships between glycemic patterns, diet, and microbiome.
Analysis of frequency of glycemic excursions	2 weeks	Hypoglycemia frequency will be assessed by: (1) number of episodes of hypoglycemia, both moderate (55-70 mg/dl) and severe (\<55 mg/dl), (2) number of episodes requiring assistance, and (4) number of episodes of hyperglycemia (\>180 mg/dl). All data will be averaged and reported as episodes per day.
Impact of activity on glycemic patterns in post-bariatric hypoglycemia	2 weeks	Activity measures (total step number per day) will be analyzed to determine relationship to changes in sensor glucose levels. Data will be integrated to determine relationships between glycemic patterns, diet, and microbiome.
Impact of diet on glycemic patterns in post-bariatric hypoglycemia	2 weeks	Dietary information will be transcribed and recorded from participants' food diaries. Data will be integrated to determine relationships between glycemic patterns, diet, and microbiome.

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States