Mechanisms of Post-Bariatric Hypoglycemia (NCT04428866) | Clinical Trial Compass
UnknownNot Applicable
Mechanisms of Post-Bariatric Hypoglycemia
United States105 participantsStarted 2020-02-26
Plain-language summary
Post-bariatric hypoglycemia (PBH) is an increasingly recognized syndrome that is incompletely understood.
The purpose of this study is to increase our level of understanding by investigating mechanisms contributing to this condition.
Participation in this study will take place over four visits, which will include the following:
* Wearing of a continuous glucose monitoring device;
* Providing a stool sample (collected at home);
* Measuring glucose and hormone levels in response to a meal;
* Measuring glucose and hormone levels in response to an injection of glucagon;
* Measuring hormone levels while glucose levels are gradually lowered, and during a controlled period of a low glucose level (hypoglycemic clamp).
Investigators will test the hypothesis that counterregulatory hormone responses are impaired in individuals with PBH, and that differences in the intestinal bacteria (microbiome) may contribute to this condition.
Who can participate
Age range18 Years β 70 Years
SexALL
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Inclusion criteria
β. For PBH group only: Males or females diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.
β. For post-RYGB group without PBH: Males or females with history of RYGB and no history of symptomatic hypoglycemia.
β. For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes.
β. Age 18-70 years of age, inclusive, at screening.
β. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
Exclusion criteria
β. Documented hypoglycemia occurring in the fasting state (\> 12 hours fast);
β. 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;
What they're measuring
1
Metabolic responses during experimental hypoglycemia induced by hypoglycemic clamp and/or mixed meal testing
Timeframe: July 2023
2
Hormonal responses during experimental hypoglycemia induced by hypoglycemic clamp and/or mixed meal testing
Timeframe: July 2023
3
Assessment of glucagon responsiveness during glucagon stimulation testing
Timeframe: July 2023
4
Assessment of hormonal responses during glucagon stimulation testing
Timeframe: July 2023
5
Analysis of microbiome differences in patients with PBH
β. Congestive heart failure, New York Heart Association class II, III or IV;
β. 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.
β. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
β. Concurrent administration of Ξ²-blocker therapy;