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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00965302

Enrollment

Registered

2009-08-25

Start date

2009-08-31

Completion date

2014-09-30

Last updated

2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Obesity

Keywords

Obesity, Diabetes mellitus, Type 2, Sleeve gastrectomy, Metabolic surgery

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.

Interventions

PROCEDURELaparoscopic 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.

BEHAVIORALIntensive medical management

Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame
Diabetes remission	1 year

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026