Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, obesity
Treatments gastric bypass, sleeve gastrectomy
Phase phase 4
Sponsor The Cleveland Clinic
Collaborator Ethicon Endo-Surgery
Start date February 2007
End date January 2012
Trial size 150 participants
Trial identifier NCT00432809, EES IIS 19900

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Intensive medical therapy for diabetes
(Active Comparator)
Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
gastric bypass RYGB
Roux-en-Y gastric bypass
(Active Comparator)
Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
sleeve gastrectomy SG
Laparoscopic sleeve gastrectomy

Primary Outcomes

Measure
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
time frame: 1 year
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
time frame: 1 year

Secondary Outcomes

Measure
Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
time frame: 1, 2, and 5 years
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.
time frame: 1, 2, and 5 years
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.
time frame: 1, 2, and 5 years.
Change in Glycated Hemoglobin (HbA1c)
time frame: 1 year - baseline
Fasting Plasma Glucose
time frame: 1 year
Glycated Hemoglobin (HbA1c)
time frame: 1 year
Body Weight
time frame: 1 year
Change in Body Weight From Baseline
time frame: 1 year
Body Mass Index (BMI)
time frame: 1 year
Change in Body Mass Index (BMI)
time frame: 1 year
Change in Systolic Blood Pressure (SBP)
time frame: 1 year
Change in High-density Lipoprotein (HDL)
time frame: 1 year
Change in Triglycerides
time frame: 1 year
Change in High-sensitivity C-reactive Protein (Hs-CRP)
time frame: 1 year
Diabetes Medication - Use of Insulin
time frame: 1 year
Diabetes Medication - Use of Biguanides
time frame: 1 year
Diabetes Medication - Use of Thiazolidinedione
time frame: 1 year
Diabetes Medication - Use of Incretin Mimetics
time frame: 1 year
Diabetes Medication - Use of Secretagogue
time frame: 1 year
Cardiovascular Medications - Lipid Lowering Agents
time frame: 1 year
Cardiovascular Medications - Beta Blocker
time frame: 1 year
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
time frame: 1 year
Cardiovascular Medications - Anticoagulants
time frame: 1 year

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently
Principal investigator Philip R Schauer, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.