Post-Gastric Bypass Hypoglycemia

NCT01933490 | Completed

• 1 other identifier: 1306M37181
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hyperinsulinemic Hypoglycemia

Keywords

hyperinsulinemic hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

a high carbohydrate test meal (control condition)

OTHER

a high carbohydrate test meal (control condition)

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

high carbohydrate test meal after pre-treatment

ACTIVE COMPARATOR

a high carbohydrate test meal after pre-treatment with rapid acting aspart insulin (insulin condition)

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

high fructose low glucose test meal

ACTIVE COMPARATOR

high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal (fructose condition)

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

Interventions

high carbohydrate test meal OTHER

a high carbohydrate test meal (control condition); high carbohydrate test meal after pre-treatment; high fructose low glucose test meal

high carbohydrate test meal after pre-treatment with rapid acting aspart insulin OTHER

a high carbohydrate test meal (control condition); high carbohydrate test meal after pre-treatment; high fructose low glucose test meal

high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal OTHER

a high carbohydrate test meal (control condition); high carbohydrate test meal after pre-treatment; high fructose low glucose test meal

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 21 years of age

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Bantle AE, Wang Q, Bantle JP. Post-Gastric Bypass Hyperinsulinemic Hypoglycemia: Fructose is a Carbohydrate Which Can Be Safely Consumed. J Clin Endocrinol Metab. 2015 Aug;100(8):3097-102. doi: 10.1210/jc.2015-1283. Epub 2015 Jun 2.

  PMID: 26037514 DERIVED

MeSH Terms

Conditions

Congenital Hyperinsulinism

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia

Study Officials

• John Bantle, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)