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Completed

NCT Number: NCT00432809

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

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.

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Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric bypass

Procedure

Roux-en-Y gastric bypass

Other names: RYGB

Sleeve gastrectomy

Procedure

Laparoscopic sleeve gastrectomy

Other names: SG

Primary outcomes

  1. Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.

    Time frame: 1 year

    The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).

  2. Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications

    Time frame: 1 year

    The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.

Secondary outcomes

  1. Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).

    Time frame: 1, 2, and 5 years

  2. Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.

    Time frame: 1, 2, and 5 years

  3. The Cost-effectiveness of Each Program and the Side Effects and /or Complications.

    Time frame: 1, 2, and 5 years.

  4. Change in Glycated Hemoglobin (HbA1c)

    Time frame: 1 year - baseline

    Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change

  5. Fasting Plasma Glucose

    Time frame: 1 year

    Fasting Plasma Glucose measured in mg/dL.

  6. Glycated Hemoglobin (HbA1c)

    Time frame: 1 year

    Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points

  7. Body Weight

    Time frame: 1 year

    Body weight in kilograms (kg) measured at 12 months

  8. Change in Body Weight From Baseline

    Time frame: 1 year

    Mean change in body weight from baseline measured in kilograms (kg)

  9. Body Mass Index (BMI)

    Time frame: 1 year

    Body Mass Index (BMI) at 12 months measured as kg/m2

  10. Change in Body Mass Index (BMI)

    Time frame: 1 year

    Change in Body Mass Index (BMI) at 12 months, measured in kg/m2

  11. Change in Systolic Blood Pressure (SBP)

    Time frame: 1 year

    Change in Systolic Blood Pressure (SBP) at 12 months

  12. Change in High-density Lipoprotein (HDL)

    Time frame: 1 year

    Percent change in high-density lipoprotein (HDL) at 12 months

  13. Change in Triglycerides

    Time frame: 1 year

    Median percent change in triglycerides at 12 months from baseline measure

  14. Change in High-sensitivity C-reactive Protein (Hs-CRP)

    Time frame: 1 year

    Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months

  15. Diabetes Medication - Use of Insulin

    Time frame: 1 year

    Number of participants taking insulin at 12 months

  16. Diabetes Medication - Use of Biguanides

    Time frame: 1 year

    Number of participants taking Biguanides at 12 months

  17. Diabetes Medication - Use of Thiazolidinedione

    Time frame: 1 year

    Number of participants using thiazolidinedione at 12 months

  18. Diabetes Medication - Use of Incretin Mimetics

    Time frame: 1 year

    Number of participants taking Incretin Mimetics

  19. Diabetes Medication - Use of Secretagogue

    Time frame: 1 year

    Number of participants taking Secretagogues at 12 months

  20. Cardiovascular Medications - Lipid Lowering Agents

    Time frame: 1 year

    Number of participants taking Lipid lowering agents at 12 months

  21. Cardiovascular Medications - Beta Blocker

    Time frame: 1 year

    Number of participants taking Beta Blockers at 12 months

  22. Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)

    Time frame: 1 year

    Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months

  23. Cardiovascular Medications - Anticoagulants

    Time frame: 1 year

    Number of participants taking anticoagulants at 12 months

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Ethicon Endo-Surgery
  • LifeScan

Registry information

Official study title

STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2007
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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