Actively Recruiting
Adipose Dysfunction, Imaging, Physiology, and Outcomes With SGLT2i's for Sleep Apnea: The ADIPOSA Study
Led by Yale University · Updated on 2025-09-11
164
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
C
Case Western Reserve University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether bexagliflozin can lower the severity of sleep apnea in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA). The study aims to see if this drug reduces anatomical and physiological traits linked to OSA and improves clinical measures of sleep apnea and sleep deficiency. Participants will receive either the drug or a placebo, with normal care maintained for six months. Participants are randomly assigned to take either bexagliflozin 20 mg once daily or a matching placebo daily for six months. Both groups will continue their usual clinical care during this period. Measurements are taken at the start and end of the study, including MRI scans to assess fat and airway structures, sleep studies to measure apnea and oxygen levels, blood tests, and other assessments of sleep quality and body composition. Throughout the study, participants will undergo various evaluations such as full ambulatory polysomnography, MRI imaging, blood biomarkers, neck circumference measurements, and questionnaires about sleep quality and daytime sleepiness. These assessments occur at baseline, three months, and six months to monitor changes. The primary outcome measure is the change in the apnea hypopnea index (AHI) after six months. Safety and adherence will be monitored during the entire study period.
CONDITIONS
Brief Title
Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and agree to follow all study procedures
- Overweight or obese with a body mass index (BMI) between 25 and 40 kg/m2
- Clinically confirmed diagnosis of obstructive sleep apnea by polysomnography or home sleep apnea testing with AHI or REI 6 15 events per hour of sleep
You will not qualify if you...
- Known non-OSA related sleep disordered breathing conditions (e.g., central hypersomnolence, neurological, neuromuscular, or pulmonary disorders)
- Use of sleep-inducing medications such as benzodiazepines, opiates, or barbiturates
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Hypersensitivity to bexagliflozin or contraindications to its use
- Severe or recurrent urinary tract or genital fungal infections
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2
- Unable to tolerate MRI due to claustrophobia or metallic implants
- Language barrier, mental incapacity, or unwillingness to participate
- Females who are pregnant, breastfeeding, or planning pregnancy
- Current or planned use of SGLT2 inhibitors, ketogenic diet, active weight loss programs, intermittent fasting, or GLP-1 receptor agonists
- Existing lower limb ulcers or severe peripheral arterial disease
- Use of UGT inducers
- Severe liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take bexagliflozin 20 mg or placebo once daily along with their routine clinical care for obstructive sleep apnea.
Visits at baseline, 3 months, and 6 months for assessments
Trial Site Locations
Total: 2 locations
1
Yale New Haven Health
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
H
Henry K Yaggi, M.D.
I
Ian J Neeland, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here