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NCT06355219Completed

Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines

Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus GLP-1 Receptor Agonists

Source: ClinicalTrials.gov · Last updated 21 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
3932 (actual)
First submitted
29 Mar 2024
Start date
1 Jan 2010
Primary completion date
31 Dec 2022
Lead sponsor
Ali Aminian
NCT number
NCT06355219

What you commit to

  • Study type: Observational
  • Participants enrolled: 3932
  • From 1 Jan 2010 to the primary completion date, 31 Dec 2022
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • ED admission within 5 days before index date
  • Received care in CCHS locations other than in Ohio and Florida.

Other illness

  • History of solid organ transplant
  • Active cancer
  • Cancer code within 1 year before index date

Lab values

  • Cardiac ejection fraction \<20% any time before index date
  • Dialysis or estimated glomerular filtration rate (eGFR) \<20 before index date.

Who the study is looking for

  • 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)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.