Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06355219
Other study ID # IRB #19-066
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date May 20, 2024

Study information

Verified date May 2024
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3932
Est. completion date May 20, 2024
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ali Aminian

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other Change HBA1c percentage Absolute change HBA1c percentage at follow up compared to index date After surgical or assigned index date to Dec 31, 2022
Other 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
Other 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
Other 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
Other 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
Primary All-cause Mortality Rate Death from all causes percentage After surgical or assigned index date to Dec 31, 2022
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2