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NCT03955952

Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

Completed Last updated 2 January 2020
What this trial tests

trial testing Bariatric Surgery in Obesity in 13,722 participants. Completed in 26 August 2019.

Timeline
5 June 2019
Primary endpoint
12 July 2019
26 August 2019

Quick facts

Lead sponsorThe Cleveland Clinic
StatusCompleted
Study typeOBSERVATIONAL
Enrollment13,722
Start date5 June 2019
Primary completion12 July 2019
Estimated completion26 August 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Cleveland Clinic

Who can join

Adults 18 to 80, any sex, with Obesity or Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity.
    Aminian A, Zajichek A, Arterburn DE, Wolski KE, et al · · 2019 · cited 329× · PMID 31475297 · DOI 10.1001/jama.2019.14231

Verify or expand the search:

Other trials of Bariatric Surgery

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other The Cleveland Clinic trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03955952.

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