NCT06053645进行中（未招募）不适用
The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 31
- 试验地点
- 2
- 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
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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 physical activity(Baseline, 12 months)
- Change in cardio fitness(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)
研究者
研究点 (2)
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标识符
- NCT 编号
- NCT06053645
- 其他研究编号
- 26-008806
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (7个月后)
- 研究完成日期
- (7个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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