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

NCT06690723 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-11-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dapagliflozin (Forxiga)

Dapagliflozin plus lifestyle modification

DRUG

Vitamin D3 ( Colecalciferol)

Vitamin D3 plus lifestyle modification

DRUG

Vitamin D3 plus Dapagliflozin

Vitamin D3 plus Dapagliflozin plus lifestyle modification

BEHAVIORAL

Lifestyle modification

Lifestyle modification alone

Sponsors & Collaborators

  • University Malaysia Sarawak

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2024-09-03
Completion
2024-09-03
FDA Drug
Yes

Countries

  • Malaysia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690723 on ClinicalTrials.gov