Clinical trial NCT00965302: 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
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: Obesity
Diabetes mellitus, Type 2
Sleeve gastrectomy
Metabolic surgery
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2009-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Diabetes remission
timeFrame: 1 year
Secondary outcomes:
measure: Weight loss
timeFrame: 1 year
measure: Obstructive sleep apnea remission
timeFrame: 1 year
measure: Fasting lipid profile
timeFrame: 1 year
measure: c-reactive protein
timeFrame: 1 year
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
affiliation: Wilford Hall Medical Center, United States Air Force
name: Jason M Pfluke, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.