NL-OMON56482招募中不适用
Cold as a therapeutic strategy to improve cardiovascular risk factors - Cold exposure and cardiovascular risk factors
niversitair Medisch Centrum0 个研究点目标入组 168 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Part 1 - Pilot study
- •For the pilot study, a subject must meet the following criteria:
- •- Males or females with Europid ethnicity OR with South Asian ethnicity (South
- •Asian ethnicity is defined as having 4 grandparents that originally descended
- •from either Bangladesh, India, Nepal, Pakistan, Afghanistan, Bhudan or Sri
- •Lanka or are from Hindu-Surinamese descent)
- •- Age between 20 and 50 years
- •- Living with overweight or obesity (Europids: BMI 25 - 35 kg/m2; South Asians:
- •BMI 23 - 35 kg/m2, since a BMI of 23 is already regarded as *overweight* in
- •South Asians; or a BMI < 35 kg/m² and a waist circumference of >=80 cm for
- •females; or a BMI < 35 kg/m² and a waist circumference of >=94 cm for male
- •Europids; or a BMI < 35 kg/m² and a waist circumference of >=90 cm for male
- •South Asians)(BMI 25 - 35 kg/m2)
- •- Capable of giving written informed consent
- •Part 2 - Cooling vest study
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Males or females with Europid ethnicity OR with South Asian ethnicity (South
- •Asian ethnicity is defined as having 4 grandparents that originally descended
- •from either Bangladesh, India, Nepal, Pakistan, Afghanistan, Bhudan or Sri
- •Lanka or are from Hindu-Surinamese descent)
- •- Age between 20 and 50 years
- •- Living with overweight or obesity (Europids: BMI 25 - 35 kg/m2; South Asians:
- •BMI 23 - 35 kg/m2, since a BMI of 23 is already regarded as *overweight* in
- •South Asians; or a BMI < 35 kg/m² and a waist circumference of >=80 cm for
- •females; or a BMI < 35 kg/m² and a waist circumference of >=94 cm for male
- •Europids; or a BMI < 35 kg/m² and a waist circumference of >=90 cm for male
- •South Asians)
- •- Capable of giving written informed consent
- •- Able to comply with the requirements and restrictions listed in the informed
- •consent form
- •Part 3 - Cold shower study
- •Inclusion criteria are largely similar compared with part 2, but here only
- •males and females with Europid ethnicity will be included.
排除标准
- •Part 1 - Pilot study
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in the pilot study:
- •- Any cardiovascular disease (i.e. ischemic heart disease, arrythmias, severe
- •heart failure, untreated hypertension)
- •- A first-degree family member with sudden cardiac death
- •- Abuse of alcohol (regularly more than 2 glasses per day) or use of any drugs
- •- Pregnancy
- •- Active cold water swimmers (at least once weekly during winter)
- •- Taking cold showers (in the past 6 weeks at least once weekly)
- •In case potential participants are active cold water swimmers or take cold
- •showers, after a wash-out period of at least 6 weeks, they can participate in
- •Part 2 & 3 - Cooling vest and cold shower study
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Diabetes mellitus (determined on basis of fasting glucose levels defined by
- •ADA criteria)
- •- Any other active endocrine disease (thyroid disease, any signs of Cushing*s
- •syndrome, adrenal disease and lipid-associated disorders such as familial
- •hypercholesterolemia)
- •- Any cardiovascular disease (i.e. ischemic heart disease, arrythmias, severe
- •heart failure, untreated hypertension)
- •- A first-degree family member with sudden cardiac death
- •- Any chronic renal or hepatic disease
- •- Abnormal laboratory values that could point towards underlying (metabolic,
- •(auto)immune) disease and/or that could influence primary and secondary
- •outcomes (e.g. dyslipidemia, leukopenia, abnormal liver function)
- •- Abuse of alcohol (regularly more than 2 glasses per day) or use of any drugs
- •- Pregnancy
- •- Participation in an intensive weight-loss program or vigorous exercise
- •program during the last year before the start of the study
- •- Use of any medication that may influence energy metabolism (e.g. β-blockers,
- •statins, antidepressants, antipsychotics), or may affect blood clotting (e.g.
- •blood thinners).
- •- Active cold water swimmers (at least once weekly during winter in the past 3
- •- Taking cold showers (in the past 3 months at least once weekly)
- •- Participation in another research project
研究者
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