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NCT00787670 · ClinicalTrials.gov registry record · NA

Impact of GBS on CVD in Type 2 Diabetes Mellitus

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
84
Enrollment target

NCT00787670: Completed NA study, sponsored by Duke University.

NCT00787670 is a NA study that has completed, run by Duke University. The registered enrollment target is 84 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00787670, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
84 participants
Enrollment target

Study Summary

This research is a NIH single site study with the aims to (1) determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2) elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess subjects with T2DM. Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study includes two groups, subjects undergoing gastric bypass surgery and a control group not undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited. Basal, 6 and 12 months assessments will include: insulin sensitivity determination, cardiovascular function by echo doppler, and DEXA scan. This study involves risk-level II procedures, however, the risks inherent to the gastric bypass surgery are not considered study-derived because subjects are enrolled from individuals that have already decided to have this surgery. We will determine protein expression profiles of inflammation-related adipokines in the subcutaneous and intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after surgically induced weight loss.

Primary Outcome

Patients with T2DM who undergo gastric bypass surgery will significantly reduce mean levels of risk factors for CVD compared with diabetic individuals with the same BMI who maintain their weight.

Interventions

  • PROCEDURE gastric bypass surgery
  • OTHER Diabetes Support and Education
  • OTHER Tissue Control Group

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2008-11
Est. Completion 2011-08
Phase NA
Duke University

1,725 total trials

What the finished NCT00787670 record still lists

NCT00787670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 3 interventions - of which gastric bypass surgery is the first listed.

NCT00787670 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00787670 about?

NCT00787670 is a clinical study titled "Impact of GBS on CVD in Type 2 Diabetes Mellitus". This research is a NIH single site study with the aims to (1) determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2) elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess sub...

What is the current status of trial NCT00787670?

This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2008-11. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00787670?

The interventions under investigation include: gastric bypass surgery (PROCEDURE), Diabetes Support and Education (OTHER), Tissue Control Group (OTHER).

Who is sponsoring clinical trial NCT00787670?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00787670's enrollment target sits among peer trials

84 983rd of 2000 higher than 1,011 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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Source: ClinicalTrials.gov NCT00787670, the US trial registry maintained by the National Library of Medicine. NCT00787670 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.