Rationale and design of the Adipose Dysfunction, Imaging, Physiology, and Outcomes with sodium-glucose cotransporter − 2 inhibitors for Sleep Apnea (ADIPOSA) study

Nov 7, 2025Contemporary clinical trials

Study plan for how diabetes drugs affect fat problems and breathing issues during sleep

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Abstract

The ADIPOSA study will enroll 164 patients with overweight/obesity and moderate to severe obstructive sleep apnea.

Sodium-glucose cotransporter-2 inhibitors (SGLT2i) may be associated with reduced severity or incidence of obstructive sleep apnea.
A randomized clinical trial will examine the effects of the SGLT2i bexagliflozin on the apnea-hypopnea index.
Secondary outcomes will assess changes in sleep health, body fat distribution, blood pressure, activity levels, and biomarkers.
The study aims to explore the mechanisms by which SGLT2i affects obstructive sleep apnea.
Findings could inform future research into SGLT2i as a potential treatment for obstructive sleep apnea.

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BACKGROUND: Obstructive sleep apnea (OSA) is a chronic condition that is associated with significant morbidity and mortality. Positive airway pressure (PAP) therapy is the gold-standard treatment for OSA but has low adherence rates. Observational studies, including post-hoc analyses of clinical trials, suggest an association between treatment with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and reduction in incident or diminished severity of prevalent OSA. However, the effects of SGLT2i therapy on the clinical severity of OSA and its mechanistic relation to underlying OSA pathophysiology have not been tested in a randomized clinical trial.

METHODS AND RESULTS: The Adipose Dysfunction, Imaging, Physiology, and Outcomes with SGLT2i's for Sleep Apnea (ADIPOSA) study is a double-blind, randomized, placebo-controlled clinical trial that will enroll 164 patients with overweight/obesity and moderate to severe OSA across two sites (Cleveland, OH and New Haven, CT). All participants will complete medical history and sleep questionnaires and undergo ambulatory polysomnography, neck and body fat imaging, 7-day actigraphy, 24-h ambulatory blood pressure monitoring, and a blood draw at baseline and 6-month follow-up. Patients will be randomized 1:1 to receive either bexagliflozin 20 mg once daily or a matching placebo. The primary outcome is a reduction in the apnea-hypopnea index, and secondary outcomes include changes in sleep health, body fat distribution, blood pressure, activity, and biomarkers of inflammation and metabolism.

CONCLUSIONS: The ADIPOSA study will identify the mechanisms underlying the effects of SGLT2i on OSA while providing evidence for future investigation to test the efficacy of pharmacologic SGLT2i on OSA prevention and treatment.

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Rationale and design of the Adipose Dysfunction, Imaging, Physiology, and Outcomes with sodium-glucose cotransporter − 2 inhibitors for Sleep Apnea (ADIPOSA) study

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