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Completed

NCT Number: NCT01933490

Post-Gastric Bypass Hypoglycemia

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).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About 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). The hypothesis to be tested are 1) pretreatment with aspart insulin will prevent, or at least reduce, the occurrence of hypoglycemia and 2) substitution of fructose for glucose in the test meal will prevent, or at least reduce, the occurrence of hypoglycemia. Plasma glucose and serum insulin will be sampled before and for four hours after the three test conditions. The primary study endpoint will be the occurrence or not of plasma glucose < 60 mg/dL after the test meals. The control meal will be compared to the insulin pre-treated test meal and, in a separate comparison, to the fructose test meal. Secondary endpoints will be comparisons between the control and active treatments in peak postprandial serum insulin, peak postprandial plasma glucose, nadir postprandial plasma glucose, and the 4-hr longitudinal course of plasma glucose measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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).

    Time frame: 4 hours after meal

    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).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Prevention of Hypoglycemia in Patients With Post-Gastric Bypass Hyperinsulinemic Hypoglycemia

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2013
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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