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Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

NCT00432809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-08-23

Study results available
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Summary

The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery \[either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy\] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.

Conditions

  • Diabetes Mellitus, Type 2
  • Obesity

Interventions

PROCEDURE

Gastric bypass

Roux-en-Y gastric bypass

PROCEDURE

Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • LifeScan

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Philip R Schauer, MD · Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2016-02-29
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00432809 on ClinicalTrials.gov