Clinical trial NCT03955952: Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes
Official title: Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus Usual Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type2 Diabetes
Bariatric Surgery Candidate
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 13722
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes patients with obesity (BMI\>=30) between 18-80 years old.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of All-Cause Mortality and Cardiovascular Outcomes
timeFrame: From index date through a maximum of 10 years
Secondary outcomes:
measure: Incidence of Major Adverse Cardiovascular Event (MACE-3)
timeFrame: From index date through a maximum of 10 years
measure: All-Cause Mortality
timeFrame: From index date through a maximum of 10 years
measure: Incidence of Coronary Disease Events
timeFrame: From index date through a maximum of 10 years
measure: Incidence of Cerebrovascular Events
timeFrame: From index date through a maximum of 10 years
measure: Incidence of Heart Failure
timeFrame: From index date through a maximum of 10 years
measure: Development of Nephropathy
timeFrame: From index date through a maximum of 10 years
measure: Incidence of Atrial Fibrillation
timeFrame: From index date through a maximum of 10 years
Other outcomes:
measure: Percentage Change in Body Weight
timeFrame: 1,3 and 5 years post-index date
measure: Percentage Change in Hemoglobin A1c
timeFrame: 1,3 and 5 years post-index date
measure: Percentage Change in Systolic Blood Pressure (SBP)
timeFrame: 1,3 and 5 years post-index date
measure: Percentage Change in Diastolic Blood Pressure (DBP)
timeFrame: 1,3 and 5 years post-index date
measure: Percentage Change in High Density Lipoprotein (HDL)
timeFrame: 1,3 and 5 years post-index date
measure: Percentage Change in Low Density Lipoprotein (LDL)
timeFrame: 1,3 and 5 years post-index date
measure: Percentage Change in Triglycerides
timeFrame: 1,3 and 5 years post-index date
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Phil Schauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aminian A, Zajichek A, Arterburn DE, Wolski KE, Brethauer SA, Schauer PR, Kattan MW, Nissen SE. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity. JAMA. 2019 Oct 1;322(13):1271-1282. doi: 10.1001/jama.2019.14231.