Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients
|ClinicalTrials.gov Identifier: NCT00965302|
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : January 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Obesity||Procedure: Laparoscopic sleeve gastrectomy Behavioral: Intensive medical management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||September 2014|
Active Comparator: Intensive medical management of Type 2 DM
Intensive medical management of Type II diabetes will include visits every three months for a year with an endocrinologist, with lifestyle counseling, weight management, regular exercise, and glucose control forming the core of the medical therapy.
Behavioral: Intensive medical management
Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.
Experimental: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy, also known as vertical sleeve gastrectomy, sleeve gastroplasty, or sleeve gastrectomy, will be performed over a 32 to 40 French sizing bougie.
- Diabetes remission [ Time Frame: 1 year ]
- Weight loss [ Time Frame: 1 year ]
- Obstructive sleep apnea remission [ Time Frame: 1 year ]
- Fasting lipid profile [ Time Frame: 1 year ]
- c-reactive protein [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965302
|United States, Texas|
|Wilford Hall Medical Center|
|San Antonio, Texas, United States, 78236|
|Principal Investigator:||Jason M Pfluke, MD||Wilford Hall Medical Center, United States Air Force|