RecruitingPhase 4NCT05612594

Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study

Adipose Dysfunction, Imaging, Physiology, and Outcomes With SGLT2i's for Sleep Apnea: The ADIPOSA Study


Sponsor

Yale University

Enrollment

164 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug). The main question it aims to answer is: * If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants * If improvement in clinical measures are because of improvement in the anatomic and physiologic traits. Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The ADIPOSA study tests whether bexagliflozin — a medication in the SGLT2 inhibitor class commonly used for diabetes — can reduce the severity of obstructive sleep apnea (OSA) in overweight or obese adults by reducing fat deposits around the airway and neck. OSA causes repeated breathing interruptions during sleep and is strongly linked to excess body fat. Adults aged 18 and older with a BMI of 25–40 and confirmed moderate-to-severe OSA (not using CPAP), without type 1 diabetes or significant kidney disease, may be eligible. Participation involves taking the study drug or placebo daily for 6 months, with sleep studies, MRI scans, and blood tests at the start and end of the study. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBexagliflozin 20 mg

15mg once daily

DRUGPlacebo

matching placebo once daily


Locations(2)

Yale New Haven Health

New Haven, Connecticut, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

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NCT05612594


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