Post-Gastric Bypass Hypoglycemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01933490
First received: August 27, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Prevention of Hypoglycemia in Patients With Post-Gastric Bypass Hyperinsulinemic Hypoglycemia

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 10
Study Start Date: August 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933490

Contacts
Contact: John Bantle, MD 612-626-0462 bantl001@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: John Bantle, MD    612-626-0462    bantl001@umn.edu   
Principal Investigator: John Bantle, MD         
Sub-Investigator: Anne Bantle, MD         
Principal Investigator: John P Bantle, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: John Bantle, MD    612-626-0462    bantl001@umn.edu   
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

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01933490     History of Changes
Other Study ID Numbers: 21849
Study First Received: August 27, 2013
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 26, 2014