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Completed

NCT Number: NCT03955952

Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.

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Key information

Conditions

Obesity Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type2 Diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

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 II diabetes
  • 18-80 years old
  • BMI>=30
  • HBA1c >6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin)

Exclusion criteria

  • History of liver, heart, or lung transplant
  • Emergency department admission within 5 days prior
  • Cancer diagnosis within 1 year prior
  • Any prior ejection fraction <20%
  • Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients)
  • Last follow-up date on or before the index date

Treatment and study plan

bariatric surgery

Procedure

Patients chosen using the following codes:

Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085

Primary outcomes

  1. Composite of All-Cause Mortality and Cardiovascular Outcomes

    Time frame: From index date through a maximum of 10 years

    Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation

Secondary outcomes

  1. Incidence of Major Adverse Cardiovascular Event (MACE-3)

    Time frame: From index date through a maximum of 10 years

    Time to first occurrence of all-cause mortality, myocardial infarction or ischemic stroke

  2. All-Cause Mortality

    Time frame: From index date through a maximum of 10 years

    Time to occurrence of death from any cause

  3. Incidence of Coronary Disease Events

    Time frame: From index date through a maximum of 10 years

    Time to first occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting

  4. Incidence of Cerebrovascular Events

    Time frame: From index date through a maximum of 10 years

    Time to first occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy

  5. Incidence of Heart Failure

    Time frame: From index date through a maximum of 10 years

    Time to first occurrence of heart failure

  6. Development of Nephropathy

    Time frame: From index date through a maximum of 10 years

    Time to first occurrence of nephropathy defined as >=2 measures of estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2 separated by at least 90 days without intervening values >=60

  7. Incidence of Atrial Fibrillation

    Time frame: From index date through a maximum of 10 years

    Time to first occurrence of atrial fibrillation defined by the following codes:

    International Classification of Diseases ICD-9: 427.31 ICD-10: i48.0, i48.1, i48.2, i48.91 Current Procedural Terminology (CPT): 93650, 93653, 93656, 93657

Other outcomes

  1. Percentage Change in Body Weight

    Time frame: 1,3 and 5 years post-index date

    Percentage change in body weight from index date to years 1, 3 and 5 post-index date

  2. Percentage Change in Hemoglobin A1c

    Time frame: 1,3 and 5 years post-index date

    Percentage change in hemoglobin A1c from index date to years 1, 3 and 5 post-index date

  3. Percentage Change in Systolic Blood Pressure (SBP)

    Time frame: 1,3 and 5 years post-index date

    Percentage change in SBP from index date to years 1, 3 and 5 post-index date

  4. Percentage Change in Diastolic Blood Pressure (DBP)

    Time frame: 1,3 and 5 years post-index date

    Percentage change in DBP from index date to years 1, 3 and 5 post-index date

  5. Percentage Change in High Density Lipoprotein (HDL)

    Time frame: 1,3 and 5 years post-index date

    Percentage change in HDL from index date to years 1, 3 and 5 post-index date

  6. Percentage Change in Low Density Lipoprotein (LDL)

    Time frame: 1,3 and 5 years post-index date

    Percentage change in LDL from index date to years 1, 3 and 5 post-index date

  7. Percentage Change in Triglycerides

    Time frame: 1,3 and 5 years post-index date

    Percentage change in triglycerides from index date to years 1, 3 and 5 post-index date

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus Usual Care

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 20, 2019
Registry last updated
Jan 2, 2020

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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