Clinical trial NCT06355219: Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines
Official title: Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus GLP-1 Receptor Agonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Obesity
Microvascular Disease
Macrovascular Disease
Major Adverse Cardiovascular Events
Nephropathy
Retinopathy
Heart Failure
All Cause Mortality
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 3932
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: All-cause Mortality Rate
timeFrame: After surgical or assigned index date to Dec 31, 2022
Secondary outcomes:
measure: Incidence of MACE
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Incidence of Nephropathy
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Incidence of Retinopathy
timeFrame: After surgical or assigned index date to Dec 31, 2022
Other outcomes:
measure: Incidence of Components of MACE Separately
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Change in weight percentage
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Change HBA1c percentage
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Cost-effectiveness of Metabolic Surgery vs GLP-1RAs
timeFrame: After surgical or assigned index date to Dec 31, 2022
measure: Incidence of Adverse Events After Metabolic Surgery
timeFrame: 90 days after surgical index date
Locations:
Study officials:
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