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Mechanisms of Diabetes Control After Weight Loss Surgery
NCT00571220 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00571220
The ClinicalTrials.gov registry entry for NCT00571220 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00571220 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00571220?
The interventions under investigation include: gastric bypass surgery (PROCEDURE), Diet induced weight loss (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00571220?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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