Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes (NCT03955952) | Clinical Trial Compass
CompletedNot Applicable
Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes
United States91,700 participantsStarted 2019-06-05
Plain-language summary
The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked all-cause mortality and cardiovascular outcomes in people with obesity and type 2 diabetes who had bariatric surgery — what did the results show, and does the data suggest any meaningful benefit for someone in my specific situation?
2Since this trial has already completed, has the data been published, and can you walk me through what the findings might mean for my own risk of heart disease or death if I pursue or skip bariatric surgery?
3This study focused on people who were already bariatric surgery candidates with type 2 diabetes — how do my current cardiovascular risk factors compare to the kinds of patients enrolled, and does that affect how relevant the results are to me?
4Are there standard-of-care options, like medication or lifestyle intervention, that I should consider alongside or instead of bariatric surgery, especially given what this completed study found about cardiovascular outcomes?
5Because this was an observational or outcomes study rather than a randomized controlled trial testing a new treatment, how confident can we be in the conclusions, and how should that shape my decision about bariatric surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.