Hyperinsulinemic Hypoglycemia Clinical Trial
Official title:
Prevention of Hypoglycemia in Patients With Post-Gastric Bypass Hyperinsulinemic Hypoglycemia
NCT number | NCT01933490 |
Other study ID # | 1306M37181 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | August 2014 |
Verified date | October 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring in some patients after gastric bypass surgery for obesity. The pathogenesis is incompletely understood but involves a robust insulin response to ingested carbohydrate. The resultant hyperinsulinemia sometimes produces hypoglycemia with neuroglycopenia, confusion and even loss of consciousness. Various treatments have been recommended including low carbohydrate diets, coingestion of the medication acarbose with carbohydrate containing meals, partial pancreatectomy and even total pancreatectomy. None is completely satisfactory. We propose to test two new potential treatments. Using a design with random assignment of three conditions we plan to compare, in 10 patients with post-gastric bypass hyperinsulinemic hypoglycemia, a high carbohydrate test meal (control condition), a high carbohydrate test meal after pre-treatment with rapid acting aspart insulin (insulin condition), and a high fructose, low glucose test meal with carbohydrate and caloric content similar to the control meal (fructose condition).
Status | Completed |
Enrollment | 10 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Participants must be at least 21 years of age - History of postprandial hypoglycemia with neuroglycopenia occurring one year or more after gastric bypass surgery - History of spontaneous correction of hypoglycemia - Normal fasting plasma glucose and serum insulin after a carbohydrate containing mixed meal, demonstration of serum insulin > 50u/UL and plasma glucose < 50mg/dL Exclusion Criteria: - Under 21 years of age |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary study endpoint will be occurrence or not of plasma glucose < 60 mg/dL during the 4 hours after the test meal (binary endpoint). | The primary study endpoint will be occurrence or not of plasma glucose < 60 mg/dL during the 4 hours after the test meal (binary endpoint). | 4 hours after meal |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03984370 -
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
|
Phase 2 | |
Recruiting |
NCT05597475 -
GLP1R-imaging in Post-RYGB Hypoglycemia
|
N/A | |
Completed |
NCT03770637 -
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
|
Phase 2 | |
Completed |
NCT03103009 -
Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia
|
Phase 1 | |
Completed |
NCT02685852 -
Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia
|
Phase 1 | |
Completed |
NCT04836273 -
Treatment of Post-bariatric Hypoglycaemia
|
Phase 2 | |
Recruiting |
NCT03930368 -
Application of Raw Corn Starch on Patients With Insulinoma
|
N/A |