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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy
* Behavioral: Intensive medical management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive medical management of Type 2 DM<br>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<br>* Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.<br>|
| Experimental: Laparoscopic sleeve gastrectomy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes remission |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 1 year | 
| Obstructive sleep apnea remission |  | 1 year | 
| Fasting lipid profile |  | 1 year | 
| c-reactive protein |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes mellitus, Type 2, Sleeve gastrectomy, Metabolic surgery