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NCT00207389 · ClinicalTrials.gov registry record

A Study to Examine Changes in GIP Plasma Levels Following Gastric Bypass Surgery in Obese Patients

A clinical trial, sponsored by Boston Medical Center.

Terminated
Registry status
5
Enrollment target

NCT00207389: Clinical Trial study, sponsored by Boston Medical Center.

NCT00207389 is a clinical trial that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00207389 was terminated before completion, sponsored by Boston Medical Center.

TERMINATED
Registry status
5 participants
Enrollment target

Study Summary

Obesity is a multinational epidemic. There is evidence that despite educational measures and increased public awareness, the number of obese individuals continues to increase. Of the numerous obesity-related comorbidities, type 2 diabetes remains one of the most significant in terms of mortality and health care costs. Gastric Bypass Surgery (GBS) not only offers an effective form of therapy for morbid obesity, but also amelioration of type 2 diabetes mellitus. The normalization of glucose levels in GBS patients occurs within days after surgery and has been shown in surgical literature to be independent of the weight loss after surgery. The proximal gut, the site of release of certain incretins, may play a role in glucose homeostasis in obese individuals with type 2 diabetes mellitus. One such incretin is GIP, which when released into the circulation during the immediate postprandial period, accentuates the insulin response to a glucose meal. It is hypothesized that overactivity of this enteroinsular axis in obese individuals produces cell resistance to insulin and subsequent type 2 diabetes mellitus. A previous study reported elevated fasting GIP levels, as well as an exaggerated GIP response to a glucose meal, in obese subjects, which was significantly reduced months after GBS following weight loss. This pilot study of obese patients scheduled for GBS will compare the serum levels of certain peptides, including GIP, following a glucose meal before and after GBS, before weight loss has occured. In order to reproduce the preoperative state, and therefore to demonstrate the physiologic change, a small group of subjects who undergo open surgery will undergo the same measurements after surgery, but using a model in which the meal traverses the stomach, duodenum and jejunum with the aid of a gastrostomy tube.

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2004-03
Est. Completion 2006-08
Boston Medical Center

253 total trials

Why NCT00207389 stopped before completion

NCT00207389 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00207389 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00207389 about?

NCT00207389 is a clinical study titled "A Study to Examine Changes in GIP Plasma Levels Following Gastric Bypass Surgery in Obese Patients". Obesity is a multinational epidemic. There is evidence that despite educational measures and increased public awareness, the number of obese individuals continues to increase. Of the numerous obesity-related comorbidities, type 2 diabetes remains one of the most significant in terms of mortality and...

What is the current status of trial NCT00207389?

This trial is currently terminated. The enrollment target is 5 participants. The study started on 2004-03. Estimated completion is 2006-08.

Who is sponsoring clinical trial NCT00207389?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00207389, the US trial registry maintained by the National Library of Medicine. NCT00207389 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.