Impact of Weight Loss on Diastolic Dysfunction in Overweight Pre-Hypertensives
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Determine if weight loss is associated with changes in separate components of cardiac function.
研究概览
简要总结
The focus of this study is to observe the impact of weight loss in overweight individuals who have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific focus is to observe the difference in diastolic dysfunction (heart function) in these individuals at the beginning of the study and then again after 24-28 weeks. Diastolic dysfunction in this population indicates an increased risk of heart failure in the future. The aim of this study is to prevent or reduce the risk of heart failure in overweight individuals with pre-hypertension.
详细描述
You will be enrolled in the study for 24-28 weeks and will be randomly assigned to one of two assigned group. One group of subjects (Intervention group) will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss. The other group will receive standard of care i.e., Information on Heart healthy diet at baseline visit (Standard of care group). The following is the time line of activities anticipated by the subject in each group. Both the groups will be screened at 3 different visits within 4 weeks to determine eligibility. If you are eligible they will be randomized to either be in Standard of care group or Intervention group. After randomization, the "Standard of care group" will come for Baseline and Final visit (24th week). The Intervention group will have 14 weekly visits with a nutritionist and 1 monthly visit, about 40-50 minutes each visit (total of 15) in 24- 28 week time frame. The second monthly session will be the final assessment visit. Both the groups will have a Baseline Assessment and a Final Assessment visit which will last about 3 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age ≥ 21 years
- •Individuals with diagnosis pre-hypertension at the time of screening, defined as either a blood pressure measurement of 130-139/85-89 mm Hg
- •Echocardiographic EF >50%
- •Echocardiographic evidence of diastolic dysfunction;
排除标准
- •Patients receiving antihypertensive medications
- •Patients receiving diabetic medication
结局指标
主要结局
Determine if weight loss is associated with changes in separate components of cardiac function.
时间窗: 32 weeks
次要结局
- Determine whether specific cardiac markers will be altered in patients with diastolic dysfunction treated with low caloric diet and exercise and if these levels will be altered in association with improvement in diastolic function.(24 weeks)
研究者
Ragavendra Baliga
Professor
Ohio State University