All Cause Mortality, Heart Failure, Macrovascular Disease, Major Adverse Cardiovascular Events, Microvascular Disease, Nephropathy, Obesity, Retinopathy, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
None listed
Sponsors
Ali Aminian
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality Rate | After surgical or assigned index date to Dec 31, 2022 | Death from all causes percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MACE | 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. |
| Incidence of Nephropathy | 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. |
| Incidence of Retinopathy | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline | 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. |
| Incidence of Components of MACE Separately | 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. |
| Incidence of Adverse Events After Metabolic Surgery | 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. |
| Cost-effectiveness of Metabolic Surgery vs GLP-1RAs | 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. |
| Change in weight percentage | After surgical or assigned index date to Dec 31, 2022 | Relative change in weight percentage at follow up compared to index date |
| Change HBA1c percentage | After surgical or assigned index date to Dec 31, 2022 | Absolute change HBA1c percentage at follow up compared to index date |
| Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions | 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 |
Outcome results
None listed