Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT01231308|
Recruitment Status : Unknown
Verified December 2012 by Weill Medical College of Cornell University.
Recruitment status was: Recruiting
First Posted : November 1, 2010
Last Update Posted : December 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Procedure: Roux-en-Y-Gastric Bypass Behavioral: Intensive lifestyle modification and Optimal medical Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Roux-en-Y-Gastric Bypass (RYGB) Versus Lifestyle Modification Plus Medical Therapy in the Treatment of Type 2 Diabetes in Overweight-to-Moderately Obese Patients: A Randomized Clinical Trial|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||October 2014|
Active Comparator: Lifestyle modification
Intensive nutritional/exercise counseling for weight loss by lifestyle modification in addition to optimum medical treatment.
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.
Experimental: Roux-en-Y-Gastric Bypass
A laparoscopic gastric bypass will be performed in the treatment of type 2 diabetes in Overweight-to-Moderately Obese Patients
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.
- The primary end-point will be the control of hyperglycemia (HbA1c <6.5% + FG<126mg/dl). [ Time Frame: Monthly after initiation of study for a minimum of 3 months, and then every monthly until HbA1c is below 7% ]
- Short (2 yrs) and long term (5 yrs.) achievement of 'adequate" glycemic control, mean change in HbA1c from baseline. [ Time Frame: Year 2 and year 5 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231308
|Contact: Melissa Marinefirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Melissa Marine 212-746-5725 email@example.com|
|Principal Investigator: Francesco Rubino, MD|
|Principal Investigator:||Francesco Rubino, MD||Weill Medical College of Cornell University|