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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965302
First Posted: August 25, 2009
Last Update Posted: January 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wilford Hall Medical Center
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2 Obesity Procedure: Laparoscopic sleeve gastrectomy Behavioral: Intensive medical management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • Diabetes remission [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Weight loss [ Time Frame: 1 year ]
  • Obstructive sleep apnea remission [ Time Frame: 1 year ]
  • Fasting lipid profile [ Time Frame: 1 year ]
  • c-reactive protein [ Time Frame: 1 year ]

Enrollment: 50
Study Start Date: August 2009
Study Completion Date: September 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Intensive medical management
Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.
Experimental: Laparoscopic sleeve gastrectomy
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
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965302


Locations
United States, Texas
Wilford Hall Medical Center
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
Wilford Hall Medical Center
Investigators
Principal Investigator: Jason M Pfluke, MD Wilford Hall Medical Center, United States Air Force
  More Information

Publications:
Responsible Party: Jason M. Pfluke, MD MAJ USAF MC, Wilford Hall Medical Center, United States Air Force
ClinicalTrials.gov Identifier: NCT00965302     History of Changes
Other Study ID Numbers: FWH20090068H
First Submitted: August 24, 2009
First Posted: August 25, 2009
Last Update Posted: January 13, 2015
Last Verified: August 2009

Keywords provided by Wilford Hall Medical Center:
Obesity
Diabetes mellitus, Type 2
Sleeve gastrectomy
Metabolic surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases