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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality Rate | Death from all causes percentage | After surgical or assigned index date to Dec 31, 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MACE | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Components of MACE Separately | 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 |
Inclusion Criteria:
For the GLP-1RA Group:
Exclusion Criteria:
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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.
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| Incidence of Nephropathy | 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 | (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 |
| Change in weight percentage | 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 | 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 | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D007674 | Kidney Diseases |
| D012164 | Retinal Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005128 | Eye Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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