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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014