Evaluating weight loss in obese adults with cardiovascular disease
The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic
This study is testing if a special clinic can help obese adults with heart problems lose weight and improve their health over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06053645 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of a cardiometabolic clinic in promoting weight loss and improving body composition in obese adults diagnosed with cardiovascular diseases over a 12-month period. Participants will be monitored for changes in percent body weight, body mass index (BMI), and visceral fat distribution. The study will involve regular self-assessments and completion of questionnaires to gather data on participants' progress and health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are obese adults with a BMI of 30 kg/m2 or higher who have been diagnosed with specific cardiovascular conditions.
Not a fit: Patients who do not meet the BMI criteria or have unstable cardiovascular conditions or other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved weight management strategies for obese patients with cardiovascular disease, potentially enhancing their overall health and quality of life.
How similar studies have performed: Previous studies have shown that structured weight loss programs can significantly benefit patients with cardiovascular diseases, suggesting that this approach may also be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Kyla Lara-Breitinger, M.D. — Mayo Clinic
- Study coordinator: Preventive/Vascular Research Team
- Email: RSTCVRUPREVENT@mayo.edu
- Phone: (507) 538-7425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.