| February 6, 2007 |
| October 13, 2009 |
| February 2007 |
| January 2011 (final data collection date for primary outcome measure) |
| Success rate of biochemical resolution of diabetes at 12 months as measured by HbA1c ≤ 6%. [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Success rate of biochemical resolution of diabetes at 12 months as measured by HbA1c ≤ 6%. |
| Complete list of historical versions of study NCT00432809 on ClinicalTrials.gov Archive Site |
- Changes in specific metabolic parameters (insulin secretion and resistance). [ Time Frame: 1, 2, and 5 years ] [ Designated as safety issue: No ]
- Changes in obesity-related comorbidities (blood pressure, dyslipidemia), quality of life, and hospitalizations. [ Time Frame: 1, 2, and 5 years ] [ Designated as safety issue: No ]
- The cost-effectiveness of each program and the side effects and /or complications. [ Time Frame: 1, 2, and 5 years. ] [ Designated as safety issue: No ]
|
- Changes in specific metabolic parameters (insulin secretion and resistance) at 1, 2 and 5 years;
- Assessments of end-organ damage (kidney, eye, cardiovascular), weight loss, and body composition at 1, 2 and 5 years;
- Changes in obesity-related comorbidities (blood pressure, dyslipidemia), quality of life, and hospitalizations at 1, 2 and 5 years;
- The cost-effectiveness of each program and the side effects and /or complications at 1, 2 and 5 years.
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| |
| Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes |
| STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently |
The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
- Diabetes Mellitus, Type 2
- Obesity
|
| Procedure: Gastric bypass surgery |
- No Intervention: Advanced medical therapy for diabetes
- Active Comparator: Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)
- Active Comparator: Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy
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- 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. Summary for patients in: Ann Intern Med. 2006 May 2;144(9):I12.
- Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5.
- Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. Review.
- [No authors listed] Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602.
- Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24.
- Nathan DM. Clinical practice. Initial management of glycemia in type 2 diabetes mellitus. N Engl J Med. 2002 Oct 24;347(17):1342-9. Review. No abstract available.
- [No authors listed] The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes. 1995 Aug;44(8):968-83.
|
| |
| Recruiting |
| 150 |
| December 2013 |
| January 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Type 2 diabetes mellitus with HbA1c > 7.0%
- Body mass index > 27 and < 43 kg/m2
- Candidate for general anesthesia
Exclusion Criteria:
- Prior bariatric surgery of any kind
- Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
- Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
- Known history of chronic liver disease (except for NAFLD/NASH)
- Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
- Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months
- Severe pulmonary disease defined as FEV1 < 50% of predicted value
- Pregnancy
|
| Both |
| 20 Years to 60 Years |
| No |
|
|
| United States |
| |
| NCT00432809 |
| Philip R. Schauer, M.D. / Director, Advanced Laparoscopic & Bariatric Surgery, Cleveland Clinic Foundation |
| EES IIS 19900 |
| The Cleveland Clinic |
- Ethicon Endo-Surgery
- LifeScan
|
| Principal Investigator: |
Philip R Schauer, MD |
Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation |
|
|
| The Cleveland Clinic |
| October 2009 |
