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NCT00444392 · ClinicalTrials.gov registry record · Phase 3

Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus

A Phase 3 study of Type 2 Diabetes Mellitus and Obese Patients, sponsored by Vanderbilt University.

Completed
Registry status
Phase 3
Development phase
9
Enrollment target
1
Study location

NCT00444392 is a Phase 3 study of Type 2 Diabetes Mellitus and Obese Patients that has completed, run by Vanderbilt University. The registered enrollment target is 9 participants, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00444392, a Phase 3 study of Type 2 Diabetes Mellitus and Obese Patients, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
Phase 3
Development phase
9 participants
Enrollment target
1
Study location

Study Summary

Central hypothesis is: Gastric bypass surgery reduces the risk of CVD in morbidly obese subjects (defined as BMI ≥35 kg/m2) with T2DM. To determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. I hypothesize that 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

  • BEHAVIORAL Calorie controlled diabetic diet for the control patients

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2007-03
Est. Completion 2009-03
Phase Phase 3

Sponsor

Vanderbilt University

430 total trials

What the Registry Record Tells You About NCT00444392

The ClinicalTrials.gov registry entry for NCT00444392 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (100% lower). The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Calorie controlled diabetic diet for the control patients is the first listed.

NCT00444392 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT00444392 about?

NCT00444392 is a clinical study titled "Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus". Central hypothesis is: Gastric bypass surgery reduces the risk of CVD in morbidly obese subjects (defined as BMI ≥35 kg/m2) with T2DM. To determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. I hypothesize that patients with T2DM who underg...

What is the current status of trial NCT00444392?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2007-03. Estimated completion is 2009-03.

What conditions does trial NCT00444392 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Obese Patients.

What interventions are being tested in trial NCT00444392?

The interventions under investigation include: Calorie controlled diabetic diet for the control patients (BEHAVIORAL).

Who is sponsoring clinical trial NCT00444392?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00444392 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.