Overview

Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

Status:
Completed

Trial end date:
2019-07-22

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Minnesota
University of Minnesota - Clinical and Translational Science Institute

Treatments:

Acarbose
Exenatide

Criteria

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.