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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: December 20, 2013
Last verified: December 2013

February 6, 2007
December 20, 2013
February 2007
January 2012   (final data collection date for primary outcome measure)
  • Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
  • Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.
Success rate of biochemical resolution of diabetes at 12 months as measured by HbA1c ≤ 6%.
Complete list of historical versions of study NCT00432809 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in Glycated Hemoglobin (HbA1c) [ Time Frame: 1 year - baseline ] [ Designated as safety issue: No ]
    Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
  • Fasting Plasma Glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fasting Plasma Glucose measured in mg/dL.
  • Glycated Hemoglobin (HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
  • Body Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Body weight in kilograms (kg) measured at 12 months
  • Change in Body Weight From Baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Mean change in body weight from baseline measured in kilograms (kg)
  • Body Mass Index (BMI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Body Mass Index (BMI) at 12 months measured as kg/m2
  • Change in Body Mass Index (BMI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
  • Change in Systolic Blood Pressure (SBP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in Systolic Blood Pressure (SBP) at 12 months
  • Change in High-density Lipoprotein (HDL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percent change in high-density lipoprotein (HDL) at 12 months
  • Change in Triglycerides [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Median percent change in triglycerides at 12 months from baseline measure
  • Change in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months
  • Diabetes Medication - Use of Insulin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking insulin at 12 months
  • Diabetes Medication - Use of Biguanides [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking Biguanides at 12 months
  • Diabetes Medication - Use of Thiazolidinedione [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants using thiazolidinedione at 12 months
  • Diabetes Medication - Use of Incretin Mimetics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking Incretin Mimetics
  • Diabetes Medication - Use of Secretagogue [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking Secretagogues at 12 months
  • Cardiovascular Medications - Lipid Lowering Agents [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking Lipid lowering agents at 12 months
  • Cardiovascular Medications - Beta Blocker [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking Beta Blockers at 12 months
  • Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
  • Cardiovascular Medications - Anticoagulants [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants taking anticoagulants at 12 months
  • Changes in specific metabolic parameters (insulin secretion and resistance) at 1, 2 and 5 years;
  • Assessments of end-organ damage (kidney, eye, cardiovascular), weight loss, and body composition at 1, 2 and 5 years;
  • Changes in obesity-related comorbidities (blood pressure, dyslipidemia), quality of life, and hospitalizations at 1, 2 and 5 years;
  • The cost-effectiveness of each program and the side effects and /or complications at 1, 2 and 5 years.
Not Provided
Not Provided
 
Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes
STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Obesity
  • Procedure: Gastric bypass
    Roux-en-Y gastric bypass
    Other Name: RYGB
  • Procedure: Sleeve Gastrectomy
    Laparoscopic sleeve gastrectomy
    Other Name: SG
  • 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
    Intervention: Procedure: Gastric bypass
  • Active Comparator: Sleeve Gastrectomy
    Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
    Intervention: Procedure: Sleeve Gastrectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
January 2016
January 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432809
EES IIS 19900
Yes
Philip Schauer, The Cleveland Clinic
The Cleveland Clinic
  • Ethicon Endo-Surgery
  • LifeScan
Principal Investigator: Philip R Schauer, MD Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation
The Cleveland Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP