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

NCT00444392 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-11-21

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Calorie controlled diabetic diet for the control patients

Calorie controlled diabetic diet for the control patients

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Alfonso Torquati, M.D. · Vanderbilt University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00444392 on ClinicalTrials.gov