Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines (M6)

May 20, 2024 updated by: Ali Aminian

Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus GLP-1 Receptor Agonists

The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with obesity (defined by body mass index [BMI] ≥30 kg/m^2) and T2DM who underwent metabolic surgery at Cleveland Clinic Health System (CCHS) from 2010 to 2017 were compared with similar patients who continuously received GLP-1 RA for at least 2 years. The study used Cleveland Clinic electronic health records (EHR), including Surescripts dispensed prescription records. Follow-up ended on December 31, 2022. To minimize the effects of confounding factors, a doubly robust estimation combining the overlap weighting and outcome regression will be utilized to compare primary and secondary end points in surgical and GLP-1RA groups.

Description

Inclusion Criteria:

  • BMI>=30 kg/m^2
  • Type 2 Diabetes Mellitus
  • 18-75 y/o
  • Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) (Surgical Cohort) at CCHS hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017

For the GLP-1RA Group:

  • Follow-up of at least 30 days after the assigned index date
  • Did not meet any of the exclusion criteria for surgical patients (see below)
  • Did not have metabolic surgery prior to assigned index date.
  • Continuously received GLP-1 RA for ≥2 years (prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date)

Exclusion Criteria:

  • History of solid organ transplant
  • Cardiac ejection fraction <20% any time before index date
  • Active cancer
  • Cancer code within 1 year before index date
  • ED admission within 5 days before index date
  • Dialysis or estimated glomerular filtration rate (eGFR) <20 before index date.
  • Received care in CCHS locations other than in Ohio and Florida.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Metabolic Surgery
Patients aged 18 years to 75 years, who had a BMI ≥30 and T2DM at the time of surgery, and who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at Cleveland Clinic Health System(CCHS) hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017.
GLP-1 RAs
Non-surgical patients at CCHS who at randomly assigned index dates had T2DM and obesity, follow-up of at least 30 days after the assigned index date, did not meet any of the exclusion criteria for surgical patients, and did not have metabolic surgery prior to the assigned index date, who continuously received GLP-1 RA for ≥2 years, defined by prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause Mortality Rate
Time Frame: After surgical or assigned index date to Dec 31, 2022
Death from all causes percentage
After surgical or assigned index date to Dec 31, 2022

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of MACE
Time Frame: After surgical or assigned index date to Dec 31, 2022
Incident major adverse cardiovascular events (MACE, composite of 4 outcomes), defined as the first occurrence of coronary artery events (unstable angina, myocardial infarction, or coronary intervention/surgery), cerebrovascular events (ischemic stroke, hemorrhagic stroke, or carotid intervention/surgery), heart failure, or atrial fibrillation.
After surgical or assigned index date to Dec 31, 2022
Incidence of Nephropathy
Time Frame: After surgical or assigned index date to Dec 31, 2022
Onset of ≥40% sustained decline in eGFR compared with baseline (calculated using the 2021 CKD-EPI equation), onset of sustained eGFR <15 mL/min/1.73 m^2, initiation of dialysis, or kidney transplant.
After surgical or assigned index date to Dec 31, 2022
Incidence of Retinopathy
Time Frame: After surgical or assigned index date to Dec 31, 2022
(1) First occurrence of retinopathy in patients who did not have such events at baseline or (2) progression to a more severe form of retinopathy in those with baseline retinopathy
After surgical or assigned index date to Dec 31, 2022

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Components of MACE Separately
Time Frame: After surgical or assigned index date to Dec 31, 2022
Incidence of each of the following MACE components separately: the first occurrence of coronary artery events (unstable angina, myocardial infarction, or coronary intervention/surgery), cerebrovascular events (ischemic stroke, hemorrhagic stroke, or carotid intervention/surgery), heart failure, or atrial fibrillation.
After surgical or assigned index date to Dec 31, 2022
Change in weight percentage
Time Frame: After surgical or assigned index date to Dec 31, 2022
Relative change in weight percentage at follow up compared to index date
After surgical or assigned index date to Dec 31, 2022
Change HBA1c percentage
Time Frame: After surgical or assigned index date to Dec 31, 2022
Absolute change HBA1c percentage at follow up compared to index date
After surgical or assigned index date to Dec 31, 2022
Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions
Time Frame: After surgical or assigned index date to Dec 31, 2022
Using dates of prescription orders and dispenses of medications for T2DM and cardio-vascular conditions
After surgical or assigned index date to Dec 31, 2022
Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline
Time Frame: After surgical or assigned index date to Dec 31, 2022
Defined as onset of ≥ 50% sustained decline in eGFR compared with baseline, onset of sustained eGFR <15 mL/min/1.73 m2, initiation of dialysis, or kidney transplant after the index date.
After surgical or assigned index date to Dec 31, 2022
Cost-effectiveness of Metabolic Surgery vs GLP-1RAs
Time Frame: After surgical or assigned index date to Dec 31, 2022
Defined as the cost per life year and the cost per quality adjusted life year (QALY) in the surgical and nonsurgical patients.
After surgical or assigned index date to Dec 31, 2022
Incidence of Adverse Events After Metabolic Surgery
Time Frame: 90 days after surgical index date
Serious complications following surgery include bleeding requiring transfusion, pulmonary adverse events, venous thromboembolism, cardiac events, renal failure requiring dialysis, gastrointestinal leak, bowel obstruction requiring surgery, gastric/anastomotic stricture or ulcer, and sepsis.
90 days after surgical index date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ali Aminian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB #19-066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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