NCT04093440Unknown不适用
CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes
Holy Cross Hospital, Florida2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Reversal of metabolic syndrome
研究概览
简要总结
Intensive lifestyle intervention has shown to be effective in high risk patient populations and has gathered support from leaders-as outlined in the 2015 consensus paper by the Cardiometabolic Health Alliance. Thus there has been a call to establish new care models that assist Metabolic Syndrome patients in reducing there risk. The investigators aim to evaluate the impact of a lifestyle intervention program on metabolic syndrome patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic syndrome patients meeting 3 of 5 criteria:
- •waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women;
- •triglycerides ≥150 mg/dl;
- •high-density lipoprotein cholesterol (HDL-C) <40 mg/dl in men and <50 mg/dl in women;
- •blood pressure ≥130/85 mm Hg
- •fasting glucose ≥100 mg/d or HgbA1c ≥ 5.71 (includes diabetics)
- •Patients requiring secondary ASCD prevention
排除标准
- •Patients with less than 5 year survival
- •Patients with cancer undergoing therapy or on palliative treatment
- •Patients with end stage heart failure
研究组 & 干预措施
Observation
Other
lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization
干预措施: lifestyle modification (Other)
结局指标
主要结局
Reversal of metabolic syndrome
时间窗: At the end of 12 months
Change in number of metabolic syndrome risk factors
次要结局
- Mortality(within three to five years of intervention)
- hemoglobin A1c(At the end of 12 months)
- waist circumference(At the end of 12 months)
- blood pressure(At the end of 12 months)
- total cholesterol(At the end of 12 months)
研究者
研究点 (2)
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