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
  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
Procedure: Sleeve Gastrectomy
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 ]
    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.


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 ]
  • 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


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: 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
Procedure: Gastric bypass
Roux-en-Y gastric bypass
Other Name: RYGB
Active Comparator: Sleeve Gastrectomy
Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Procedure: Sleeve Gastrectomy
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
Results First Received: November 9, 2012
Last Updated: December 20, 2013
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 April 15, 2014