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Post-Gastric Bypass Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01933490
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Hyperinsulinemic Hypoglycemia 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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prevention of Hypoglycemia in Patients With Post-Gastric Bypass Hyperinsulinemic Hypoglycemia
Study Start Date : August 2013
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
a high carbohydrate test meal (control condition)
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


Outcome Measures

Primary Outcome Measures :
  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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933490


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: John Bantle, MD University of Minnesota - Clinical and Translational Science Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01933490     History of Changes
Other Study ID Numbers: 21849
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
hyperinsulinemic hypoglycemia

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs