Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

Completed · Phase 1 · Has a placebo group

Conditions studied: Hyperinsulinemic Hypoglycemia

In brief

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.

Key facts

Study ID

NCT02685852

Run by

University of Minnesota

People needed

11

Starts

2016-02-01

Expected to finish

2019-07-22

Last updated by the study team

2021-05-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• Chronic or acute diseases of the liver.
• 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.
• Chronic or acute diseases of the kidneys.
• Known malignancies and must not have a family history of medullary thyroid cancer.
• History of pre-RYGB hypoglycemia symptoms or low documented plasma glucose preoperatively.
• Pregnant or plans to become pregnant throughout study duration
• Breastfeeding
• Medication exclusions in addition to the current use of diabetes medications. Subjects will be excluded if they have previously taken GLP-1 agonists.

Where it is running

• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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