Post-Gastric Bypass Hypoglycemia

October 30, 2019 updated by: University of Minnesota

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Active Comparator: high carbohydrate test meal after pre-treatment
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
Active Comparator: high fructose low glucose test meal
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 hours after meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306M37181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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