Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231308
|Contact: Melissa Marineemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Melissa Marine 212-746-5725 firstname.lastname@example.org|
|Principal Investigator: Francesco Rubino, MD|
|Principal Investigator:||Francesco Rubino, MD||Weill Medical College of Cornell University|