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NCT03955952 · ClinicalTrials.gov registry record
Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 13,722
- Enrollment target
NCT03955952: Completed study, sponsored by The Cleveland Clinic.
NCT03955952 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 13,722 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03955952 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 13,722 participants
- Enrollment target
Study 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.
Primary Outcome
First occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation
Interventions
- PROCEDURE Bariatric Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,722 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2019-08-26 |
What the finished NCT03955952 record still lists
NCT03955952 is an observational study that tracks outcomes without assigning an intervention. Its 13,722 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Bariatric Surgery is the first listed.
NCT03955952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03955952 about?
NCT03955952 is a clinical study titled "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 2004-20...
What is the current status of trial NCT03955952?
This trial is currently completed. The enrollment target is 13,722 participants. The study started on 2019-06-05. Estimated completion is 2019-08-26.
What interventions are being tested in trial NCT03955952?
The interventions under investigation include: Bariatric Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03955952?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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