Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

Not Applicable

Terminated

• Conditions: Obesity; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Intensive medical management; Procedure: Laparoscopic sleeve gastrectomy

• Registration Number: NCT00965302
• Lead Sponsor: 59th Medical Wing

Brief Summary

The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2012-12
• Study Completion: 2014-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diabetes mellitus, Type 2
• Body Mass Index (BMI) 30-34.9
• Able to understand and comply with study process

Exclusion Criteria

• Pregnancy
• Prior bariatric surgery
• Diabetes mellitus, Type 1
• Renal impairment
• Cirrhosis or portal hypertension
• Diabetes secondary to a specific condition
• Recent internal malignancy (<5 years)
• Recent major vascular event
• Drug or alcohol dependence
• Uncontrolled psychiatric disease
• Crippling cardiopulmonary disease
• Prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive medical management of Type 2 DM	Intensive medical management	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.
Laparoscopic sleeve gastrectomy	Laparoscopic sleeve gastrectomy	Laparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.

Primary Outcome Measures

Name	Time	Method
Diabetes remission	1 year

Secondary Outcome Measures

Name	Time	Method
c-reactive protein	1 year
Weight loss	1 year
Obstructive sleep apnea remission	1 year
Fasting lipid profile	1 year

Trial Locations

Locations (1)

Wilford Hall Medical Center; 🇺🇸 San Antonio, Texas, United States