Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia (NCT06986603) | Clinical Trial Compass
Active ā Not RecruitingPhase 4
Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia
United States28 participantsStarted 2024-11-26
Plain-language summary
The purpose of the study is to determine how blood sugar levels in individuals with and without hypoglycemia after bariatric surgery respond to different doses of glucagon, a hormone that is usually present in your body that regulates blood sugar levels. In this study, there will be 4 visits to the clinical research center. In the first visit, medical history and physical exam will be performed, and blood samples will be taken to assess overall health. During visit 2, a continuous glucose monitor will be placed under the skin. (This may be combined with visit 1, depending on the schedule of visits.) In visit 3, we will test the effect of a total of 4 different doses of glucagon, in increasing doses. In visit 4, we will test the effect of a total of 3 doses of glucagon, in decreasing doses. For both visit 3 and 4, we will infuse labeled stable glucose to allow us to measure how much glucose the body is making, and will measure levels of hormones which regulate glucose, such as insulin and glucagon.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Age 18-70 years of age, inclusive, at screening.
ā. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
ā. Males or females diagnosed with ongoing PBH, at least 2 years following Roux-en-Y gastric bypass (RYGB), with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad.
Exclusion criteria
ā. Documented hypoglycemia occurring only in the fasting state (\>12 hours fast);
ā. Current diabetes, defined as hemoglobin A1c \>6.5% or use of diabetes medications, except for acarbose or miglitol;
ā. Hepatic disease, including serum ALT or AST greater than 2 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
ā. Congestive heart failure, NYHA class II, III or IV;
What they're measuring
1
Incremental change in plasma glucose levels after administration of exogenous glucagon for each dose.
Timeframe: Measurement of glucose levels will occur at baseline, and then every 5 minutes, for 60 minutes.
2
Endogenous glucose production (EGP) after administration of exogenous glucagon.
Timeframe: Measurement of glucose levels will occur at visit 2, at baseline, and then every 5 minutes after the first dose of glucagon, for 120 minutes
. History of myocardial infarction, unstable angina or revascularization within the past 6 months.
ā. Two or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
ā. History of recurrent syncope (unrelated to hypoglycemia) or active diagnosis of a cardiac arrhythmia;