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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ethicon Endo-Surgery
LifeScan
Information provided by (Responsible Party):
Philip Schauer, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00432809
First received: February 6, 2007
Last updated: March 15, 2012
Last verified: March 2012
  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 surgery
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:


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 ]

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 ]

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: 1
Advanced medical therapy for diabetes
Active Comparator: 2
Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB)
Procedure: Gastric bypass surgery
Roux-en-Y gastric bypass
Other Name: RYGB
Active Comparator: 3
Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy
Procedure: Gastric bypass surgery
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:
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):
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
Last Updated: March 15, 2012
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 May 23, 2013