Vitamin D and SGLT-2 Inhibitor in CPAP-naive Obstructive Sleep Apnea

Sponsor
University Malaysia Sarawak
Study ID
NCT06690723
Phase
PHASE3
Status
Completed

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (Forxiga) — DRUG
    Dapagliflozin plus lifestyle modification
  • Vitamin D3 ( Colecalciferol) — DRUG
    Vitamin D3 plus lifestyle modification
  • Vitamin D3 plus Dapagliflozin — DRUG
    Vitamin D3 plus Dapagliflozin plus lifestyle modification
  • Lifestyle modification — BEHAVIORAL
    Lifestyle modification alone

Study Details

The purpose of this study is to determine if vitamin D supplement and SGLT-2 inhibitor treatment combination can improve cardiovascular risks in patients with OSA and hypertension, on top of lifestyle modification, before treatment with CPAP therapy. It aims to answer if this treatment combination can improve i) renin-angiotensin-aldosterone system (RAAS) parameters, ii) cardio-metabolic risks iii) sleepiness symptoms and quality of life Researchers will compare the outcome with 3 other groups of treatment: vitamin D supplementation and lifestyle modification, SGLT2-inhibitor and lifestyle modification, and lifestyle modification alone. Participants will need to answer 2 questionnaires (Epworth Sleepiness Scale, WHO-quality of life), undergo anthropometric measurements (blood pressure, pulse rate, weight, height, waist circumference, neck circumference), blood taking (aldosterone, renin, vitamin D, calcium, albumin, phosphate, intact parathyroid hormone, kidney function, blood sugar, cholesterol and hsCRP), ultrasound of liver, ultrasound of blood vessel, and heart rate variability assessment using Polar H10 device and 24-hour Holter monitoring.

Key Dates

Start date
Jun 8, 2022
Status verified
Nov 2024
Primary completion
Sep 3, 2024
Completion
Sep 3, 2024

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Lifestyle modification
    Participants are taught about lifestyle modification including diet and exercise
  • Active Comparator: Vitamin D3 (Cholecalciferol)
    Participants are given vitamin D3 for 16 weeks on top of lifestyle modification advice
  • Active Comparator: Dapagliflozin (Forxiga)
    Participants are given Dapagliflozin 10mg daily for 16 weeks on top of lifestyle modification advice
  • Active Comparator: Vitamin D3 plus Dapagliflozin
    Participants are given vitamin D3 plus Dapagliflozin 10mg daily for 16 weeks on top of lifestyle modification advice

Primary Outcome Measure

hsCRP (mg/L) [ Time Frame: 16 weeks ]

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