NCT06690723CompletedPhase 3
Vitamin D and SGLT-2 Inhibitor in CPAP-naive Obstructive Sleep Apnea
Exploring the Synergistic Effect of Vitamin D and SGLT-2 Inhibitor on Cardio-metabolic Markers and the Renin Angiotensin Aldosterone System in CPAP-naive Obstructive Sleep Apnea Population
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 10 Oct 2024
- Start date
- 8 Jun 2022
- Primary completion date
- 3 Sept 2024
- Lead sponsor
- University Malaysia Sarawak
- NCT number
- NCT06690723
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 160
- From 8 Jun 2022 to the primary completion date, 3 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergone surgical or medical therapy for PA
- Long term use of systemic steroids
- On current use of continuous positive airway pressure (CPAP) therapy for OSA
- Recent myocardial infarction or stroke (within 6 weeks prior to study)
- On SGLT-2 inhibitor
Other illness
- Diagnosis of secondary hypertension
- Presence of thyroid dysfunction or suspected Cushing's syndrome
- Congestive heart failure
- Underlying type 1 diabetes or history of ketoacidosis
- History of severe recurrent genito-urinary tract infections
- History of, or increased risk of, bone fractures
Lab values
- Chronic kidney disease (eGFR\<30ml/min/1.73m2)
Other
- Long-standing atrial fibrillation, ie atrial fibrillation \>12 months in duration
- On vitamin D supplements
- Pregnant
Who the study is looking for
- Aged 18 years and above
- Obstructive sleep apnea (OSA) confirmed on sleep study
- Hypertension (SBP\>140mmHg and/or DBP\>90mmHg) or on anti-hypertensive
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Malaysia Sarawak Coordinator of this site? Confirm its status | Sarawak | Malaysia | Unknown status |
Related publications
- Unveiling the benefits of Vitamin D3 with SGLT-2 inhibitors for hypertensive obese obstructive sleep apnea patients.J Transl Med · 2025 · PMID 40055713
This page is information, not medical advice. Discuss any trial with your doctor.