Hyperinsulinemic Hypoglycemia Clinical Trial
Official title:
A Pilot Study Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia Post-RYGB
Verified date | April 2021 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.
Status | Completed |
Enrollment | 11 |
Est. completion date | July 22, 2019 |
Est. primary completion date | July 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. must have undergone RYGB and subsequently developed post-prandial hypoglycemia (defined as at least 3 episodes over a six-month period with documented capillary blood sugars [<60 mg/dL with hypoglycemic symptoms). Subjects may also have had a formal mixed meal tolerance test with post meal blood sugar <60 mg/dL. 2. Subjects who otherwise meet the study criteria above with hypoglycemia symptoms but who do not have documented hypoglycemia by plasma measurement may undergo a screening visit to document the requisite levels for consideration into the study. Exclusion Criteria: 1. Chronic or acute diseases of the liver. 2. Chronic or acute diseases of the pancreas (including type 1 diabetes or pancreatitis or a history of pancreatitis). Subjects may have a diagnosis of type 2 diabetes but must no longer require diabetes medication. 3. Chronic or acute diseases of the kidneys. 4. Known malignancies and must not have a family history of medullary thyroid cancer. 5. History of pre-RYGB hypoglycemia symptoms or low documented plasma glucose preoperatively. 6. Pregnant or plans to become pregnant throughout study duration 7. Breastfeeding 8. Medication exclusions in addition to the current use of diabetes medications. Subjects will be excluded if they have previously taken GLP-1 agonists. |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose area under the curve (AUC) following treatment for each 4-hour test period | Each time point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) will be used to calculate AUC using the trapezoidal method. | During the 4-hour test period | |
Primary | Presence of hypoglycemia | If at each time-point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) plasma glucose is <60 mg/dL, participants will be defined as hypoglycemic | 15, 30, 45, 60, 90, 120, 180 and 240 minutes | |
Secondary | Minimum post-prandial blood sugar level (mg/dL) | The lowest post-prandial blood glucose level at any time point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) may be used as the minimum post-prandial blood sugar level (mg/dL). | post meal test | |
Secondary | Change in post-prandial blood glucose from 0min to 120min | % change in blood glucose 0min to 120min | 0min to 120min | |
Secondary | Change in post-prandial Insulin levels (mcg/mL) | % change in insulin 0min to 120min | 0min to 120min |
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