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临床试验/NCT05232201
NCT05232201Unknown不适用

Elucidation of Vitamin D Levels and Heart Rate Variability Influence on Endothelial Function Via Renin Angiotensin Aldosterone System Augmentation in Obstructive Sleep Apnea

University Malaysia Sarawak1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Renin angiotensin aldosterone system

研究概览

简要总结

The role of obstructive sleep apnea (OSA) in contributing to hyperaldosteronism, which can lead to increased morbidity and mortality, is less well-established. The vitamin D levels and sympathetic activity of patients with obesity and OSA have not been explored in detail. In this cohort, the role of vitamin D and sympathetic activity, either individually or in combination, on augmenting the renin-angiotensin-aldosterone system (RAAS) causing more endothelial dysfunction remains elusive.

We aim to evaluate renin angiotensin aldosterone system in OSA population; elucidate relationship between aldosterone and vitamin D levels in patients with OSA; and to determine association between aldosterone level and vitamin D deficiency with cardio-metabolic derangement in patients with OSA.

This is a cross-sectional study involving 150 patients confirmed to have OSA. Participants who fulfil study criteria and consent to study will have blood withdrawn for aldosterone, renin, 25OHD levels with bone profile, and metabolic profile; undergo ultrasound flow mediated dilatation of brachial artery to assess endothelial function; ultrasound of hepatobiliary system to assess fatty liver; 24-hour Holter monitoring to assess sympathetic function; WHOQOLBREF to assess quality of life and Pittsburgh Sleep Quality Index to assess sleep quality.

详细描述

Obstructive sleep apnea (OSA), which is closely related to obesity, is a chronic, serious and potentially life-threatening sleep-related breathing disorder, characterized by periodic narrowing and obstruction of the pharyngeal airway during sleep, occurring in 25% to 58% of men and 10% to 37% of women.

Untreated OSA leads to lost productivity and workplace accidents resulting in injury and fatality. Patients with OSA are involved in automobile accidents more frequently than other licensed drivers. OSA is also associated with long-term health complications, including metabolic disorders and cardiovascular diseases, which is the leading cause of death worldwide.

For decades, we have believed that the activation of RAAS, mainly in response to intravascular volume contraction, regulated the biosynthesis of aldosterone. There is growing evidence that suggests aldosterone secretion to be beyond RAAS regulation. There is new evidence that both plasma and urinary aldosterone concentrations are increased in people with obesity. This relationship, on the other hand, is less studied for patients with OSA, with equivocal data. Aldosterone levels contributed to severity of OSA in patients with primary aldosteronism and resistant hypertension. In a limited number of studies, primary aldosteronism was found to be more frequent in patients with OSA whereas patients with OSA had higher aldosterone levels and prevalence of PA.

Vitamin D plays an important role in calcium homeostasis and metabolism. It is involved in maintenance of calcium and phosphorus levels in the blood, and bone content. Vitamin D is also implicated in several non-skeletal conditions, such as cardiovascular disease, cancer, autoimmune disorders and diabetes mellitus. Vitamin D deficiency has been associated with worse cardiovascular outcomes. Vitamin D deficiency augments the RAAS leading to elevated aldosterone and lowered renin. This is supported by a reduction in aldosterone and an increase in plasma renin in patients with heart failure, arterial hypertension and primary aldosteronism when repleted with vitamin D.

Sympathetic and parasympathetic nervous system interactively regulate visceral functions to maintain the body homeostatic milieu, and to enable reaction and adaptation to external and internal stressor stimuli. Patients with OSA exhibit high levels of sympathetic activity during sleep as well as when awake. Aldosterone is found to augment sympathetic activity in patients with resistant hypertension.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Aged 18 years and above
  • Obese (BMI>27.5kg/m2)
  • Confirmed OSA (AHI>5)

排除标准

  • Secondary causes of obesity, such as Cushing's syndrome or thyroid dysfunction
  • Secondary hypertension, including undergone treatment for primary aldosteronism
  • Chronic kidney disease (eGFR<30ml/min/1.73m2)
  • Recent myocardial infarct or stroke within 6 weeks prior to study
  • Congestive heart failure
  • Long-standing atrial fibrillation >12 months
  • On current CPAP use
  • On vitamin D supplements

结局指标

主要结局

Renin angiotensin aldosterone system

时间窗: 30 months

To evaluate renin angiotensin aldosterone system in OSA population

Aldosterone and vitamin D levels

时间窗: 30 months

To elucidate relationship between aldosterone and vitamin D levels in patients with OSA

Aldosterone level and vitamin D deficiency with cardio-metabolic derangement

时间窗: 30 months

To determine association between aldosterone level and vitamin D deficiency with cardio-metabolic derangement in patients with OSA

次要结局

未报告次要终点

研究者

发起方
University Malaysia Sarawak
申办方类型
Other
责任方
Sponsor

研究点 (1)

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