Hyperinsulinemic Hypoglycemia | Post-Gastric Bypass Hypoglycemia
Hyperinsulinemic Hypoglycemia research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:high carbohydrate test meal
Other:high carbohydrate test meal after pre-treatment with rapid acting aspart insulin
Other:high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
a high carbohydrate test meal (control condition)a high carbohydrate test meal (control condition)
high carbohydrate test meal after pre-treatmenta high carbohydrate test meal after pre-treatment with rapid acting aspart insulin (insulin condition)
high fructose low glucose test mealhigh fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal (fructose condition)
Start Date: August 2013
Completed Date: August 2014
Primary Outcome: 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).
Study sponsors, principal investigator, and references
Principal Investigator: John Bantle, MD
Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute