Recruiting

Cardiometabolic Clinic

Sponsor:

Mayo Clinic

Code:

NCT06053645

Conditions

Cardiovascular Diseases

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to evaluate the impact of a cardiometabolic clinic on percent body weight loss, body mass index (BMI), and visceral adiposity distribution in obese adults with cardiovascular disease (CVD) at 12 months.

Conditions

Cardiovascular Diseases

Obesity

Study ID

NCT06053645

Start date

Apr 22, 2024

Status verified date

Oct, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • BMI ≥30 kg/m2
  • At least one of the following CVD: atrial fibrillation (AF), coronary artery disease (CAD), HFpEF (heart failure with preserved ejection fraction), HFrEF (heart failure with reduced ejection fraction), ACHD (adult congenital heart disease), or valvular heart disease
  • Patients evaluated in the Cardiometabolic clinic
  • Willingness to complete questionnaires/surveys
  • Ability to complete monthly self-assessments at home

Exclusion Criteria:

  • BMI <30 kg/m2
  • Pregnancy or lactating women
  • Hemodynamically unstable CVD
  • Active malignancy
  • Autoimmune or systemic inflammatory diseases
  • Severe renal or hepatic failure
  • Being considered unsafe to participate as determined by the study physician
  • Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic medications, or other medications as determined by the study NP or physician
  • Patients with active psychosis, mania, or substance use disorders

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Percent body weight loss [ Time Frame: 12 months ]
  • Change in Body Mass Index (BMI) [ Time Frame: Baseline, 12 months ]
  • Change in visceral adiposity distribution [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Preventive/Vascular Research Team

(507) 538-7425RSTCVRUPREVENT@mayo.edu

Kyla Lara-Breitinger, M.D.

(507) 284-4441Lara.Kyla@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Preventive/Vascular Research Team

(507) 538-7425RSTCVRUPREVENT@mayo.edu

Kyla Lara-Breitinger, M.D.

(507) 284-4441Lara.Kyla@mayo.edu

Principal Investigator:

Kyla Lara-Breitinger, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-20.