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Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes

NCT01231308 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-12-24

No results posted yet for this study

Summary

The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal medical therapy versus Intensive lifestyle modification and optimal medical therapy in the treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2; the lower BMI cut-off will be 26kg/m2 in patients of Asian descent).

This is a single center, prospective randomized study. The study at the Weill College Medical College Diabetes Surgery Center. This study is intended to be a pilot investigation whose results can inform clinicians and researchers for future larger or multi-site trials of diabetes surgery. This study will also be used for the definition of a "core" protocol for independent randomized clinical trials to be carried out at various centers participating in a multinational consortium.

Conditions

Interventions

PROCEDURE

Roux-en-Y-Gastric Bypass

Standard laparoscopic gastric bypass. Preoperative preparation will include antibiotic prophylaxis given less than 60 minutes prior to making the first incision. Under general anesthesia with endotracheal intubation, a laparoscopic gastric bypass will be performed in the usual fashion.

BEHAVIORAL

Intensive lifestyle modification and Optimal medical Therapy

Very low calorie diet consisting of 5 feedings: 2 liquid meal replacements, 2 low-calorie snacks, and 1 small meal of known caloric content. After 10% weight loss is achieved, the subjects will received individualized nutrition sessions beginning bi-weekly but extending time intervals as the weight loss progresses.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Francesco Rubino, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-10-31
Completion
2014-10-31

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 NCT01231308 on ClinicalTrials.gov