Vitamin D Levels and Heart Rate Variability on Endothelial Function Via RAAS Augmentation in OSA

NCT05232201 | Unknown

• 1 other identifier: RAAS in OSA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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 Participants who fulfil study criteria and consent to study will have blood withdrawn for aldosterone, renin, 25OHD levels with bone profile, and metabolic profile; undergo ultrasound flow mediated dilatation of brachial artery to assess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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Renin angiotensin aldosterone system

  To evaluate renin angiotensin aldosterone system in OSA population

  30 months

• Aldosterone and vitamin D levels

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

  30 months

• Aldosterone level and vitamin D deficiency with cardio-metabolic derangement

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

  30 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obstructive sleep apnea confirmed on sleep study (AHI\>5)

You may qualify if:

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

You may not qualify if:

• 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
• Pregnant

Sponsors & Collaborators

• University Malaysia Sarawak: lead

Study Sites (1)

Universiti Malaysia Sarawak

Kuching, Sarawak, 93350, Malaysia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Huai Heng Loh

  Universiti Malaysia Sarawak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huai Heng H Loh

CONTACT

+60122010765; hhloh@unimas.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 9, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)