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

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 Procedure: Sleeve Gastrectomy	Phase 4

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:

MedlinePlus related topics: Diabetes Diabetes Medicines 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 ]
The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.

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 ]
Change in Glycated Hemoglobin (HbA1c) [ Time Frame: 1 year - baseline ] [ Designated as safety issue: No ]
Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
Fasting Plasma Glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Fasting Plasma Glucose measured in mg/dL.
Glycated Hemoglobin (HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
Body Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Body weight in kilograms (kg) measured at 12 months
Change in Body Weight From Baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mean change in body weight from baseline measured in kilograms (kg)
Body Mass Index (BMI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Body Mass Index (BMI) at 12 months measured as kg/m2
Change in Body Mass Index (BMI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
Change in Systolic Blood Pressure (SBP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in Systolic Blood Pressure (SBP) at 12 months
Change in High-density Lipoprotein (HDL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Percent change in high-density lipoprotein (HDL) at 12 months
Change in Triglycerides [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Median percent change in triglycerides at 12 months from baseline measure
Change in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months
Diabetes Medication - Use of Insulin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking insulin at 12 months
Diabetes Medication - Use of Biguanides [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking Biguanides at 12 months
Diabetes Medication - Use of Thiazolidinedione [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants using thiazolidinedione at 12 months
Diabetes Medication - Use of Incretin Mimetics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking Incretin Mimetics
Diabetes Medication - Use of Secretagogue [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking Secretagogues at 12 months
Cardiovascular Medications - Lipid Lowering Agents [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking Lipid lowering agents at 12 months
Cardiovascular Medications - Beta Blocker [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking Beta Blockers at 12 months
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
Cardiovascular Medications - Anticoagulants [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of participants taking anticoagulants at 12 months

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

Arms	Assigned Interventions
No Intervention: Medical therapy Intensive medical therapy for diabetes
Active Comparator: Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Procedure: Gastric bypass Roux-en-Y gastric bypass Other Name: RYGB
Active Comparator: Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy	Procedure: Sleeve Gastrectomy Laparoscopic sleeve gastrectomy Other Name: SG

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012 Mar 26. [Epub ahead of print]

Responsible Party:	Philip Schauer, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00432809 History of Changes
Other Study ID Numbers:	EES IIS 19900
Study First Received:	February 6, 2007
Results First Received:	November 9, 2012
Last Updated:	June 7, 2013
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 June 17, 2013