Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT00432809
• Recruitment Status: Completed
• First Posted: February 8, 2007
• Results First Posted: June 11, 2013
• Last Update Posted: August 23, 2017
• Sponsor: The Cleveland Clinic
• Collaborators: Ethicon Endo-Surgery; LifeScan
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Obesity	Procedure: Gastric bypass; Procedure: Sleeve Gastrectomy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently
• Study Start Date: February 2007
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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. 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.

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. 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.

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 costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.

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

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.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00432809
• Other Study ID Numbers: EES IIS 19900
• First Posted: February 8, 2007
• Results First Posted: June 11, 2013
• Last Update Posted: August 23, 2017
• Last Verified: July 2017

Keywords provided by The Cleveland Clinic:

Diabetes Mellitus, Type 2; Obesity

Additional relevant MeSH terms:

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