Active — Not RecruitingNot Applicable

Hypoglycemia and the Gut Microbiome

United States28 participantsStarted 2019-02-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females diagnosed with ongoing post-bariatric, post-gastric surgery or other forms of postprandial hypoglycemia with prior episodes of neuroglycopenia
✓. Age 18-65 years of age, inclusive, at screening.
✓. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion criteria

✕. Documented hypoglycemia occurring in the fasting state (\> 12 hours fast);
✕. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
✕. Hepatic disease, including serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
✕. Congestive heart failure, New York Heart Association (NYHA) class II, III or IV;
✕. History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
✕. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
✕. Concurrent administration of β-blocker therapy;
✕. History of a cerebrovascular accident;

What they're measuring

Analysis of cumulative duration of hypoglycemia

Timeframe: 2 weeks

Trial details

NCT IDNCT03385707

SponsorJoslin Diabetes Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11-01

View on ClinicalTrials.gov More Hypoglycemia trials