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

Obesity Clinical Trial

Official title:

STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00432809
• Other study ID #: EES IIS 19900
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 6, 2007
• Last updated: December 20, 2013
• Start date: February 2007
• Est. completion date: January 2016

Study information

• Verified date: December 2013
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 2016
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Procedure:
• Gastric bypass
Roux-en-Y gastric bypass
• Sleeve Gastrectomy
Laparoscopic sleeve gastrectomy

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
The Cleveland Clinic	Ethicon Endo-Surgery, LifeScan

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View 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. — View 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. Erratum in: Lancet 1999 Aug 14;354(9178):602. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).		1, 2, and 5 years	No
Secondary	Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.		1, 2, and 5 years	No
Secondary	The Cost-effectiveness of Each Program and the Side Effects and /or Complications.		1, 2, and 5 years.	No
Secondary	Change in Glycated Hemoglobin (HbA1c)	Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change	1 year - baseline	No
Secondary	Fasting Plasma Glucose	Fasting Plasma Glucose measured in mg/dL.	1 year	No
Secondary	Glycated Hemoglobin (HbA1c)	Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points	1 year	No
Secondary	Body Weight	Body weight in kilograms (kg) measured at 12 months	1 year	No
Secondary	Change in Body Weight From Baseline	Mean change in body weight from baseline measured in kilograms (kg)	1 year	No
Secondary	Body Mass Index (BMI)	Body Mass Index (BMI) at 12 months measured as kg/m2	1 year	No
Secondary	Change in Body Mass Index (BMI)	Change in Body Mass Index (BMI) at 12 months, measured in kg/m2	1 year	No
Secondary	Change in Systolic Blood Pressure (SBP)	Change in Systolic Blood Pressure (SBP) at 12 months	1 year	No
Secondary	Change in High-density Lipoprotein (HDL)	Percent change in high-density lipoprotein (HDL) at 12 months	1 year	No
Secondary	Change in Triglycerides	Median percent change in triglycerides at 12 months from baseline measure	1 year	No
Secondary	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	No
Secondary	Diabetes Medication - Use of Insulin	Number of participants taking insulin at 12 months	1 year	No
Secondary	Diabetes Medication - Use of Biguanides	Number of participants taking Biguanides at 12 months	1 year	No
Secondary	Diabetes Medication - Use of Thiazolidinedione	Number of participants using thiazolidinedione at 12 months	1 year	No
Secondary	Diabetes Medication - Use of Incretin Mimetics	Number of participants taking Incretin Mimetics	1 year	No
Secondary	Diabetes Medication - Use of Secretagogue	Number of participants taking Secretagogues at 12 months	1 year	No
Secondary	Cardiovascular Medications - Lipid Lowering Agents	Number of participants taking Lipid lowering agents at 12 months	1 year	No
Secondary	Cardiovascular Medications - Beta Blocker	Number of participants taking Beta Blockers at 12 months	1 year	No
Secondary	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	No
Secondary	Cardiovascular Medications - Anticoagulants	Number of participants taking anticoagulants at 12 months	1 year	No