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NCT00571220 · ClinicalTrials.gov registry record
Mechanisms of Diabetes Control After Weight Loss Surgery
A clinical trial of Obesity and Gastric Bypass Surgery, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT00571220: Completed study of Obesity and Gastric Bypass Surgery, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00571220 is a study of Obesity and Gastric Bypass Surgery that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 20 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00571220, a study of Obesity and Gastric Bypass Surgery, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.
Primary Outcome
Change in incretin (gastric inhibitory peptide \[GIP\] and glucagon-like peptide-1 \[GLP-1\])
Conditions Studied
Interventions
- PROCEDURE gastric bypass surgery
- OTHER Diet induced weight loss
Study Locations (1)
New York
- St Luke's Roosevelt Hospital Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-09 |
| Est. Completion | 2010-12 |
What the finished NCT00571220 record still lists
NCT00571220 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which gastric bypass surgery is the first listed.
NCT00571220 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00571220 about?
NCT00571220 is a clinical study titled "Mechanisms of Diabetes Control After Weight Loss Surgery". Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far b...
What is the current status of trial NCT00571220?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2005-09. Estimated completion is 2010-12.
What conditions does trial NCT00571220 study?
This clinical trial studies the following conditions: Obesity, Gastric Bypass Surgery.
What interventions are being tested in trial NCT00571220?
The interventions under investigation include: gastric bypass surgery (PROCEDURE), Diet induced weight loss (OTHER).
Who is sponsoring clinical trial NCT00571220?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00571220 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00571220's enrollment target sits among peer trials
20 946th of 1053 higher than 80 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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.
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