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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00965302
• Other study ID #: FWH20090068H
• Status: Terminated
• Phase: N/A
• Start date: August 2009
• Est. completion date: September 2014

Study information

• Verified date: April 2023
• Source: 59th Medical Wing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

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.

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

Locations

Country	Name	City	State
United States	Wilford Hall Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
59th Medical Wing

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes remission		1 year
Secondary	Weight loss		1 year
Secondary	Obstructive sleep apnea remission		1 year
Secondary	Fasting lipid profile		1 year
Secondary	c-reactive protein		1 year