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

59th Medical Wing

Status: Terminated

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Intensive medical management; Procedure: Laparoscopic sleeve gastrectomy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00965302

FWH20090068H

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intensive medical management of Type 2 DM

Active Comparator group

Description:

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.

Treatment:

Behavioral: Intensive medical management

Laparoscopic sleeve gastrectomy

Experimental group

Description:

Laparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.

Treatment:

Procedure: Laparoscopic sleeve gastrectomy