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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Procedure: Gastric bypass; Procedure: Sleeve Gastrectomy

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: RYGB
Active Comparator: Sleeve Gastrectomy; Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy	Procedure: Sleeve Gastrectomy; Laparoscopic sleeve gastrectomy; Other Names: SG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.	The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).	1 year
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications	The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).		1, 2, and 5 years
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.		1, 2, and 5 years
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.		1, 2, and 5 years.
Change in Glycated Hemoglobin (HbA1c)	Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change	1 year - baseline
Fasting Plasma Glucose	Fasting Plasma Glucose measured in mg/dL.	1 year
Glycated Hemoglobin (HbA1c)	Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points	1 year
Body Weight	Body weight in kilograms (kg) measured at 12 months	1 year
Change in Body Weight From Baseline	Mean change in body weight from baseline measured in kilograms (kg)	1 year
Body Mass Index (BMI)	Body Mass Index (BMI) at 12 months measured as kg/m2	1 year
Change in Body Mass Index (BMI)	Change in Body Mass Index (BMI) at 12 months, measured in kg/m2	1 year
Change in Systolic Blood Pressure (SBP)	Change in Systolic Blood Pressure (SBP) at 12 months	1 year
Change in High-density Lipoprotein (HDL)	Percent change in high-density lipoprotein (HDL) at 12 months	1 year
Change in Triglycerides	Median percent change in triglycerides at 12 months from baseline measure	1 year
Change in High-sensitivity C-reactive Protein (Hs-CRP)	Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months	1 year
Diabetes Medication - Use of Insulin	Number of participants taking insulin at 12 months	1 year
Diabetes Medication - Use of Biguanides	Number of participants taking Biguanides at 12 months	1 year
Diabetes Medication - Use of Thiazolidinedione	Number of participants using thiazolidinedione at 12 months	1 year
Diabetes Medication - Use of Incretin Mimetics	Number of participants taking Incretin Mimetics	1 year
Diabetes Medication - Use of Secretagogue	Number of participants taking Secretagogues at 12 months	1 year
Cardiovascular Medications - Lipid Lowering Agents	Number of participants taking Lipid lowering agents at 12 months	1 year
Cardiovascular Medications - Beta Blocker	Number of participants taking Beta Blockers at 12 months	1 year
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)	Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months	1 year
Cardiovascular Medications - Anticoagulants	Number of participants taking anticoagulants at 12 months	1 year

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Ethicon Endo-Surgery; LifeScan
• Investigators: Principal Investigator: Philip R Schauer, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. doi: 10.1097/01.sla.0000089851.41115.1b.
• Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993.
• 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. doi: 10.2337/diacare.21.4.518.
• Nathan DM. Clinical practice. Initial management of glycemia in type 2 diabetes mellitus. N Engl J Med. 2002 Oct 24;347(17):1342-9. doi: 10.1056/NEJMcp021106. No abstract available.
• Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.
• Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Aminian A, Brethauer SA, Navaneethan SD, Singh RP, Pothier CE, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med. 2017 Feb 16;376(7):641-651. doi: 10.1056/NEJMoa1600869.
• Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD, Aminian A, Pothier CE, Kim ES, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. N Engl J Med. 2014 May 22;370(21):2002-13. doi: 10.1056/NEJMoa1401329. Epub 2014 Mar 31.
• Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25.
• 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 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 6, 2007
• First Submitted That Met QC Criteria: February 6, 2007
• First Posted (Estimate): February 8, 2007

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Diabetes Mellitus, Type 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: EES IIS 19900