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Unveiling the benefits of Vitamin D3 with SGLT-2 inhibitors for hypertensive obese obstructive sleep apnea patients.

  • 2025-03-07
  • Journal of translational medicine 23(1)
    • Huai Heng Loh
    • Siow Phing Tay
    • Ai Jiun Koa
    • Mei Ching Yong
    • Asri Said
    • Chee Shee Chai
    • Natasya Marliana Abdul Malik
    • Anselm Ting Su
    • Bonnie Bao Chee Tang
    • Florence Hui Sieng Tan
    • Norlela Sukor

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 163
Population
hypertensive obese OSA patients
Methods
Patients who fulfilled the study criteria were randomized to receive: (i) Dapagliflozin, (ii) vitamin D3, (iii) Dapagliflozin plus vitamin D3, or (iv) no treatment, for 16 weeks
Blinding
Open-label
Duration
16 weeks
Funding
Unclear
  • Large Human Trial

Background

Obstructive sleep apnea (OSA) is associated with poorer quality of life (QoL) and increased cardiovascular risks, which may be exacerbated by hypovitaminosis D. Sodium glucose transporter-2 inhibitor (SGLT2i) provides cardiovascular benefits beyond glycemic control. As vitamin D3 and SGLT2i act through different pathways with similar mechanisms in improving cardio-metabolic health, this study aimed to investigate the synergistic effects of this combination therapy in improving these parameters and QoL in hypertensive obese OSA patients.

Methods

Patients who fulfilled the study criteria were randomized to receive: (i) Dapagliflozin, (ii) vitamin D3, (iii) Dapagliflozin plus vitamin D3, or (iv) no treatment, for 16 weeks. The parameters evaluated included anthropometric measurements, uric acid, HbA1c, lipid profile, steatotic liver disease grade, plasma aldosterone concentration, plasma renin concentration, ultrasound flow-mediated dilatation of brachial artery, hsCRP, heart rate variability (HRV), Epworth Sleepiness Scale (ESS), and QoL scores.

Results

A total of 163 patients were recruited and 153 completed the study. The combination of vitamin D3 and Dapagliflozin treatment led to significant improvements in metabolic parameters and nocturnal heart rates, and prevented deterioration of HRV, with healthier HRV at the end of study visit compared to the control group. Only the combination group exhibited improvements in both ESS and QoL scores.

Conclusions

This is the first study to demonstrate beneficial effects of combining vitamin D3 and SGLT2i in cardio-metabolic outcomes and QoL in hypertensive obese OSA patients. These findings highlight the potential of this combination therapy in addressing the cardio-metabolic challenges and QoL in this patient population.

Trials registration

NCT06690723. Registered 10 October 2024-Retrospectively registered, https://register.

Clinicaltrials

gov/prs/beta/studies/S000EWGF00000085/recordSummary.

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