Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines

NCT06355219 | Completed

• 1 other identifier: IRB #19-066
• Study Type: observational
• Target: 3,932
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus; Obesity; Microvascular Disease; Macrovascular Disease; Major Adverse Cardiovascular Events; Nephropathy; Retinopathy; Heart Failure; All Cause Mortality

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality Rate

  Death from all causes percentage

  After surgical or assigned index date to Dec 31, 2022

Secondary Outcomes (3)

• Incidence of MACE

  After surgical or assigned index date to Dec 31, 2022

• Incidence of Nephropathy

  After surgical or assigned index date to Dec 31, 2022

• Incidence of Retinopathy

  After surgical or assigned index date to Dec 31, 2022

Other Outcomes (7)

• Incidence of Components of MACE Separately

  After surgical or assigned index date to Dec 31, 2022

• Change in weight percentage

  After surgical or assigned index date to Dec 31, 2022

• Change HBA1c percentage

  After surgical or assigned index date to Dec 31, 2022

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• BMI\>=30 kg/m\^2
• Type 2 Diabetes Mellitus
• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Ali Aminian: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Kidney Diseases; Retinal Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Eye Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Bariatric and Metabolic Institute

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 9, 2024
• Study Start: January 1, 2010
• Primary Completion: December 31, 2022
• Study Completion: May 20, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share