Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes - Full Text View

Sponsor:	The Cleveland Clinic
Collaborators:	Ethicon Endo-Surgery LifeScan
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00432809

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Obesity	Procedure: Gastric bypass surgery	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Obesity Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Success rate of biochemical resolution of diabetes at 12 months as measured by HbA1c ≤ 6%. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	150
Study Start Date:	February 2007
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Advanced medical therapy for diabetes
Active Comparator: 2 Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)	Procedure: Gastric bypass surgery Roux-en-Y gastric bypass Other Names: LRYGBP LSG
Active Comparator: 3 Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy	Procedure: Gastric bypass surgery Laparoscopic sleeve gastrectomy

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432809

Locations

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Ethicon Endo-Surgery

LifeScan

Investigators

Principal Investigator:

Philip R Schauer, MD

Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation

More Information

Publications:

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.

Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic cost of diabetes mellitus in the US in 2002. Diabetes Care 26:917-932, 2003.

Responsible Party:	Philip R. Schauer, M.D. / Director, Advanced Laparoscopic & Bariatric Surgery, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:	NCT00432809 History of Changes
Other Study ID Numbers:	EES IIS 19900
Study First Received:	February 6, 2007
Last Updated:	August 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

Diabetes Mellitus, Type 2
Obesity

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 13, 2012