Post-Gastric Bypass Hypoglycemia
Primary Purpose
Hyperinsulinemic Hypoglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high carbohydrate test meal
high carbohydrate test meal after pre-treatment with rapid acting aspart insulin
high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal
Sponsored by
About this trial
This is an interventional health services research trial for Hyperinsulinemic Hypoglycemia focused on measuring hyperinsulinemic hypoglycemia
Eligibility 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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
a high carbohydrate test meal (control condition)
high carbohydrate test meal after pre-treatment
high fructose low glucose test meal
Arm Description
a high carbohydrate test meal (control condition)
a high carbohydrate test meal after pre-treatment with rapid acting aspart insulin (insulin condition)
high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal (fructose condition)
Outcomes
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01933490
First Posted
August 27, 2013
Last Updated
October 30, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01933490
Brief Title
Post-Gastric Bypass Hypoglycemia
Official Title
Prevention of Hypoglycemia in Patients With Post-Gastric Bypass Hyperinsulinemic Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperinsulinemic Hypoglycemia
Keywords
hyperinsulinemic hypoglycemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a high carbohydrate test meal (control condition)
Arm Type
Other
Arm Description
a high carbohydrate test meal (control condition)
Arm Title
high carbohydrate test meal after pre-treatment
Arm Type
Active Comparator
Arm Description
a high carbohydrate test meal after pre-treatment with rapid acting aspart insulin (insulin condition)
Arm Title
high fructose low glucose test meal
Arm Type
Active Comparator
Arm Description
high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal (fructose condition)
Intervention Type
Other
Intervention Name(s)
high carbohydrate test meal
Intervention Type
Other
Intervention Name(s)
high carbohydrate test meal after pre-treatment with rapid acting aspart insulin
Intervention Type
Other
Intervention Name(s)
high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal
Primary Outcome Measure Information:
Title
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).
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Bantle, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26037514
Citation
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.
Results Reference
derived
Learn more about this trial
Post-Gastric Bypass Hypoglycemia
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