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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Effectiveness of Bariatric Surgery Versus Medical Management to Induce Diabetes Remission in Diabetic Patients With BMI 30-35

NCT01423877

Diabetes

COMPLETED

A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2

NCT01197963

Type 2 Diabetes Mellitus

TERMINATED NA

Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

NCT00540462

Type II Diabetes Mellitus

UNKNOWN PHASE4

Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese Patients

NCT00428571

Type 2 Diabetes

TERMINATED NA

SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients

NCT02076880

Severe Obesity Type 2 Diabetes

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Intensive medical management

Intervention Type BEHAVIORAL

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

Laparoscopic sleeve gastrectomy

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

Group Type EXPERIMENTAL

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Intensive medical management

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No