Clinical trial NCT00432809: Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes
Official title: STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
name: LifeScan
First posted: 2007-02-08
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
timeFrame: 1 year
measure: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
timeFrame: 1 year
Secondary outcomes:
measure: Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
timeFrame: 1, 2, and 5 years
measure: Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.
timeFrame: 1, 2, and 5 years
measure: The Cost-effectiveness of Each Program and the Side Effects and /or Complications.
timeFrame: 1, 2, and 5 years.
measure: Change in Glycated Hemoglobin (HbA1c)
timeFrame: 1 year - baseline
measure: Fasting Plasma Glucose
timeFrame: 1 year
measure: Glycated Hemoglobin (HbA1c)
timeFrame: 1 year
measure: Body Weight
timeFrame: 1 year
measure: Change in Body Weight From Baseline
timeFrame: 1 year
measure: Body Mass Index (BMI)
timeFrame: 1 year
measure: Change in Body Mass Index (BMI)
timeFrame: 1 year
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: 1 year
measure: Change in High-density Lipoprotein (HDL)
timeFrame: 1 year
measure: Change in Triglycerides
timeFrame: 1 year
measure: Change in High-sensitivity C-reactive Protein (Hs-CRP)
timeFrame: 1 year
measure: Diabetes Medication - Use of Insulin
timeFrame: 1 year
measure: Diabetes Medication - Use of Biguanides
timeFrame: 1 year
measure: Diabetes Medication - Use of Thiazolidinedione
timeFrame: 1 year
measure: Diabetes Medication - Use of Incretin Mimetics
timeFrame: 1 year
measure: Diabetes Medication - Use of Secretagogue
timeFrame: 1 year
measure: Cardiovascular Medications - Lipid Lowering Agents
timeFrame: 1 year
measure: Cardiovascular Medications - Beta Blocker
timeFrame: 1 year
measure: Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
timeFrame: 1 year
measure: Cardiovascular Medications - Anticoagulants
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation
name: Philip R Schauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.