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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03955952
Other study ID # 19-066
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2019
Est. completion date August 26, 2019

Study information

Verified date December 2019
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 13722
Est. completion date August 26, 2019
Est. primary completion date July 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
Bariatric Surgery
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

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Percentage Change in Body Weight Percentage change in body weight from index date to years 1, 3 and 5 post-index date 1,3 and 5 years post-index date
Other Percentage Change in Hemoglobin A1c Percentage change in hemoglobin A1c from index date to years 1, 3 and 5 post-index date 1,3 and 5 years post-index date
Other Percentage Change in Systolic Blood Pressure (SBP) Percentage change in SBP from index date to years 1, 3 and 5 post-index date 1,3 and 5 years post-index date
Other Percentage Change in Diastolic Blood Pressure (DBP) Percentage change in DBP from index date to years 1, 3 and 5 post-index date 1,3 and 5 years post-index date
Other Percentage Change in High Density Lipoprotein (HDL) Percentage change in HDL from index date to years 1, 3 and 5 post-index date 1,3 and 5 years post-index date
Other Percentage Change in Low Density Lipoprotein (LDL) Percentage change in LDL from index date to years 1, 3 and 5 post-index date 1,3 and 5 years post-index date
Other Percentage Change in Triglycerides Percentage change in triglycerides from index date to years 1, 3 and 5 post-index date 1,3 and 5 years post-index date
Primary Composite of All-Cause Mortality and Cardiovascular Outcomes Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation From index date through a maximum of 10 years
Secondary Incidence of Major Adverse Cardiovascular Event (MACE-3) Time to first occurrence of all-cause mortality, myocardial infarction or ischemic stroke From index date through a maximum of 10 years
Secondary All-Cause Mortality Time to occurrence of death from any cause From index date through a maximum of 10 years
Secondary Incidence of Coronary Disease Events Time to first occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting From index date through a maximum of 10 years
Secondary Incidence of Cerebrovascular Events Time to first occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy From index date through a maximum of 10 years
Secondary Incidence of Heart Failure Time to first occurrence of heart failure From index date through a maximum of 10 years
Secondary Development of Nephropathy 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 From index date through a maximum of 10 years
Secondary Incidence of Atrial Fibrillation 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
From index date through a maximum of 10 years
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