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临床试验/NCT04198519
NCT04198519Unknown不适用

Effects of Weight Loss on Vascular Function in Obese Individuals With Poor Cardiovascular Health

Mario Fritsch Neves4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年11月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
4
主要终点
Pulse wave velocity

研究概览

简要总结

To evaluate the effect of weight loss on vascular function in obese with poor cardiovascular health. The investigators will evaluate the effects of weight loss on total and central body adiposity, blood pressure, central hemodynamic parameters, arterial stiffness, endothelial function, apnea-hypopnea index, insulin resistance and inflammatory markers.

详细描述

Excessive adipose tissue is associated with adverse metabolic effects and is an important risk factor for chronic diseases. According to the American Heart Association, most cardiovascular events can be prevented by adhering to healthy practices, reflecting cardiovascular health as poor, intermediate, and ideal. Methods: Both sexes, aged between 40 and 70 years, with body mass index ≥ 30 and < 40 kg/m² will be included and clinical, anthropometric, body composition and laboratory tests will be assessed. In vascular tests, the investigators will evaluate the sympathetic tone using a frequency meter (Polar® RS800), oscillometric pulse wave analysis by Mobil-O-Grah®, post-occlusive microvascular reactivity and carotid ultrasound to measure intimamedia thickness. In the sleep study, the investigators will analyze the presence and degree of obstructive sleep apnea (OSA) through the home polysomnography device (WatchPAT 200®). The first visit will be for screening, clinical and anthropometric evaluation. On the second visit, the vascular tests, instructions and device delivery for sleep study will be performed. Patients will return the following day to return the WatchPAT and to receive the hypocaloric nutritional intervention (800kcal reduction of daily total energy value), which should be followed for 16 weeks. Eight weeks after the beginning of the nutritional intervention a new visit will be scheduled for clinical, nutritional assessment and dietary adjustment. After completing 16 weeks, the patients will return for clinical, laboratory, nutritional, vascular and sleep tests.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The participants do not know if they are classified as poor or intermediate/ideal cardiovascular health.

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes;
  • Age between 40 and 70 years;
  • Body mass index (BMI) ≥ 30 kg/m² and <40 kg/m².

排除标准

  • Systolic blood pressure ≥ 160 and/or diastolic blood pressure ≥ 100 mmHg;
  • Diabetes mellitus; Hormone replacement therapy;
  • Evidence of secondary hypertension;
  • Clinically evident changes in thyroid function;
  • Acute or chronic kidney or liver disease;
  • History of cancer in the last 5 years;
  • Clinically evident coronary disease with a history of acute myocardial infarction and/or myocardial revascularization, clinical signs of heart failure, cardiac arrhythmia or clinically significant valve disease;
  • Previous stroke;

结局指标

主要结局

Pulse wave velocity

时间窗: Change in PWV after 16-week dietary intervention

Pulse wave velocity (PWV) will be evaluated by oscillometric monitoring system via Mobil-O -Graph®

次要结局

  • Endothelial function(Change in endothelial function after 16-week dietary intervention)

研究者

发起方
Mario Fritsch Neves
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mario Fritsch Neves

Clinical Professor

Hospital Universitario Pedro Ernesto

研究点 (4)

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