Study 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.
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Aug 2009
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 25, 2023
April 1, 2023
3.3 years
August 24, 2009
April 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diabetes remission
1 year
Secondary Outcomes (4)
Weight loss
1 year
Obstructive sleep apnea remission
1 year
Fasting lipid profile
1 year
c-reactive protein
1 year
Study Arms (2)
Intensive medical management of Type 2 DM
ACTIVE COMPARATORIntensive 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
EXPERIMENTALLaparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.
Interventions
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.
Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.
Eligibility Criteria
You may qualify if:
- Diabetes mellitus, Type 2
- Body Mass Index (BMI) 30-34.9
- Able to understand and comply with study process
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wilford Hall Medical Center
San Antonio, Texas, 78236, United States
Related Publications (5)
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.
PMID: 16670131BACKGROUNDKakoulidis 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.
PMID: 18996758BACKGROUNDLee 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.
PMID: 17356932BACKGROUNDDixon 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.
PMID: 18212316BACKGROUNDCohen 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.
PMID: 16925363BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason M Pfluke, MD
Wilford Hall Medical Center, United States Air Force
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 25, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2012
Study Completion
September 1, 2014
Last Updated
April 25, 2023
Record last verified: 2023-04