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

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy
Intensive medical management
Sponsored by
59th Medical Wing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Obesity, Diabetes mellitus, Type 2, Sleeve gastrectomy, Metabolic surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Wilford Hall Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intensive medical management of Type 2 DM

Laparoscopic sleeve gastrectomy

Arm 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.

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

Outcomes

Primary Outcome Measures

Diabetes remission

Secondary Outcome Measures

Weight loss
Obstructive sleep apnea remission
Fasting lipid profile
c-reactive protein

Full Information

First Posted
August 24, 2009
Last Updated
April 24, 2023
Sponsor
59th Medical Wing
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1. Study Identification

Unique Protocol Identification Number
NCT00965302
Brief Title
Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients
Official Title
Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Investigator did not submit an annual continuation report with the Institutional Review Board and the study was officially removed from IRB regulatory oversight on Sep 2014, based on 32 CFR 219.109e. The study officially expired/terminated.
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
59th Medical Wing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
Obesity, Diabetes mellitus, Type 2, Sleeve gastrectomy, Metabolic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive medical management of Type 2 DM
Arm Type
Active Comparator
Arm 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.
Arm Title
Laparoscopic sleeve gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy
Intervention Description
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
Behavioral
Intervention Name(s)
Intensive medical management
Intervention Description
Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.
Primary Outcome Measure Information:
Title
Diabetes remission
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
1 year
Title
Obstructive sleep apnea remission
Time Frame
1 year
Title
Fasting lipid profile
Time Frame
1 year
Title
c-reactive protein
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Pfluke, MD
Organizational Affiliation
Wilford Hall Medical Center, United States Air Force
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilford Hall Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16670131
Citation
O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006 May 2;144(9):625-33. doi: 10.7326/0003-4819-144-9-200605020-00005.
Results Reference
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PubMed Identifier
18996758
Citation
Kakoulidis TP, Karringer A, Gloaguen T, Arvidsson D. Initial results with sleeve gastrectomy for patients with class I obesity (BMI 30-35 kg/m2). Surg Obes Relat Dis. 2009 Jul-Aug;5(4):425-8. doi: 10.1016/j.soard.2008.09.009. Epub 2008 Sep 26.
Results Reference
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PubMed Identifier
17356932
Citation
Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. doi: 10.1007/s00464-007-9276-y. Epub 2007 Mar 14.
Results Reference
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PubMed Identifier
18212316
Citation
Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008 Jan 23;299(3):316-23. doi: 10.1001/jama.299.3.316.
Results Reference
background
PubMed Identifier
16925363
Citation
Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006 May-Jun;2(3):401-4, discussion 404. doi: 10.1016/j.soard.2006.02.011.
Results Reference
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Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

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