The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent body weight loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percent body weight loss
时间窗: 12 months
Total percent body weight loss will be reported at 12 months based on the following formula: (Starting baseline weight minus current weight) / (starting baseline weight) x 100 equals % of body weight loss.
Change in Body Mass Index (BMI)
时间窗: Baseline, 12 months
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703
Change in visceral adiposity distribution
时间窗: Baseline, 12 months
Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA).
次要结局
- Change in Peak Tricuspid Regurgitation (TR) Velocity(Baseline, 12 months)
- Change in point of care glucose(Baseline, 12 months)
- Change in Blood Pressure(Baseline, 12 months)
- Change in six-minute walk test(Baseline, 12 months)
- Change in psychosocial distress as measured by the Weight Bias Internalization-Modified (WBIS-M) scale(Baseline, 12 months)
- Change in quality of diet(Baseline, 12 months)
- Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D)(Baseline, 12 months)
- Change in E/e'(Baseline, 12 months)
- Change in Right Atrial (RA) Pressure(Baseline, 12 months)
- Change in heart rate with detection of arrhythmia(Baseline, 12 months)
- Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R)(Baseline, 12 months)
- Change in psychosocial distress as measured by Adverse Childhood Experience (ACE) Questionnaire(Baseline, 12 months)
- Change in functional aerobic capacity (VO2 Max)(Baseline, 12 months)
- Change in artificial intelligence electrocardiogram (AI-ECG) age(Baseline, 12 months)
- Change in Left Atrial (LA) volume index(Baseline, 12 months)
- Change in physical activity(Baseline, 12 months)
- Change in cardio fitness(Baseline, 12 months)
研究者
Kyla M. Lara-Breitinger
Principal Investigator
Mayo Clinic