Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955952
• Other study ID #: 19-066
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type2 Diabetes

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