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NCT01933490 · ClinicalTrials.gov registry record · NA
Post-Gastric Bypass Hypoglycemia
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01933490: Completed NA study, sponsored by University of Minnesota.
NCT01933490 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01933490, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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).
Primary Outcome
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).
Interventions
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-08 |
| Phase | NA |
What the finished NCT01933490 record still lists
NCT01933490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which high carbohydrate test meal is the first listed.
NCT01933490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01933490 about?
NCT01933490 is a clinical study titled "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 sometime...
What is the current status of trial NCT01933490?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2013-08. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01933490?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01933490?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01933490's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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