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Completed

NCT Number: NCT06355219

Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines

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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Key information

Conditions

Type 2 Diabetes Mellitus All Cause Mortality Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Heart Failure Kidney Diseases Macrovascular Disease Major Adverse Cardiovascular Events Male Urogenital Diseases Metabolic Diseases Microvascular Disease Nephropathy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Retinal Diseases Retinopathy Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All-cause Mortality Rate

    Time frame: After surgical or assigned index date to Dec 31, 2022

    Death from all causes percentage

Secondary outcomes

  1. Incidence of MACE

    Time frame: 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.

  2. Incidence of Nephropathy

    Time frame: 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.

  3. Incidence of Retinopathy

    Time frame: 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 outcomes

  1. Incidence of Components of MACE Separately

    Time frame: 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.

  2. Change in weight percentage

    Time frame: After surgical or assigned index date to Dec 31, 2022

    Relative change in weight percentage at follow up compared to index date

  3. Change HBA1c percentage

    Time frame: After surgical or assigned index date to Dec 31, 2022

    Absolute change HBA1c percentage at follow up compared to index date

  4. Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions

    Time frame: 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

  5. Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline

    Time frame: 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.

  6. Cost-effectiveness of Metabolic Surgery vs GLP-1RAs

    Time frame: 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.

  7. Incidence of Adverse Events After Metabolic Surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ali Aminian

Other

Registry information

Official study title

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

Acronym: M6

Important dates

Study start
2010
Primary completion
2022
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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