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ObesityNCT03955952

Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

An observational study of Obesity and Type2 Diabetes, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Bariatric Surgery
Type of treatment
Surgery or procedure
How many people
91,700 participants
Where
1 siteUnited States
Study dates
5 Jun 2019to 26 Aug 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Type 2 diabetes patients with obesity (BMI>=30) between 18-80 years old.

Who may be able to join

  • Type II diabetes
  • 18-80 years old
  • BMI>=30
  • HBA1c >6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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

The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes.

Read the detailed 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.

Being tested
Bariatric Surgery
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric SurgeryProcedure or 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

Study groups in NCT03955952
Study groupRoleWhat they receive
Bariatric SurgeryPatients with type 2 diabetes with BMI >=30 that underwent bariatric surgery
Receives: Procedure: Bariatric Surgery
Non-Surgical ControlMatched non-surgical controls with type 2 diabetes and BMI >=30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-Cause Mortality and/or Cardiovascular Outcomes

    First occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation

    Measured: From index date through a maximum of 8 years

Secondary outcomes (7)

  1. Major Adverse Cardiovascular Event (MACE-3)

    First occurrence of all-cause mortality, myocardial infarction or ischemic stroke

    Measured: From index date through a maximum of 8 years

  2. All-Cause Mortality

    Occurrence of death from any cause

    Measured: From index date through a maximum of 8 years

  3. Coronary Disease Events

    First occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting

    Measured: From index date through a maximum of 8 years

  4. Cerebrovascular Events

    First occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy

    Measured: From index date through a maximum of 8 years

  5. Heart Failure

    First occurrence of heart failure

    Measured: From index date through a maximum of 8 years

  6. Development of Nephropathy

    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

    Measured: From index date through a maximum of 8 years

  7. Atrial Fibrillation

    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

    Measured: From index date through a maximum of 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start5 Jun 2019
  3. Primary completion12 Jul 2019
  4. Study completion26 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
91,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955952
Sponsor's protocol ID
19-066
Status last verified
Jul 2026
First submitted
16 May 2019
Last updated
3 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31475297

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Type2 Diabetes, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Mortality and/or Cardiovascular Outcomes (time frame: From index date through a maximum of 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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