Using bexagliflozin to treat sleep apnea in overweight or obese adults
Adipose Dysfunction, Imaging, Physiology, and Outcomes With SGLT2i's for Sleep Apnea: The ADIPOSA Study
This study is testing if a medication called bexagliflozin can help overweight or obese adults with sleep apnea breathe better while they sleep.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT05612594 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of bexagliflozin, a sodium glucose cotransporter 2 inhibitor, in reducing the severity of obstructive sleep apnea (OSA) in overweight or obese adults. Participants will be randomly assigned to receive either the drug or a placebo for six months, alongside standard clinical care. The study will measure various clinical and physiological traits related to OSA, including the apnea hypopnea index (AHI) and changes in body fat distribution. The trial is conducted at two centers: Yale New Haven Health and University Hospitals Cleveland Medical Center.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults with a clinically confirmed diagnosis of moderate to severe obstructive sleep apnea.
Not a fit: Patients with non-OSA related sleep disorders or those with type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall health for patients suffering from sleep apnea.
How similar studies have performed: While the use of SGLT2 inhibitors for sleep apnea is a novel approach, other studies have shown promising results with similar interventions in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Able to provide informed consent and stated willingness to comply with all study procedures and availability for the duration of the study
* Overweight or obese (body mass index 25-40 kg/m2)
* Clinically confirmed diagnosis of obstructive sleep apnea by one of the following methods:
a. Polysomnography: AHI ≥15/hour sleep or b. Home sleep apnea testing: Respiratory event index (REI) ≥15/hour sleep
* AHI: apnea-hypopnea index (apneas + hypopneas / total sleep time in hours)
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Known non-OSA related conditions associated with sleep disordered breathing (e.g., central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder)
* Use of sleep-inducing medications (e.g. benzodiazepines, opiates, barbiturates)
* Type 1 diabetes mellitus
* History of diabetic ketoacidosis
* Known hypersensitivity reaction to bexagliflozin or any of its constituents or any contraindication to bexagliflozin use
* Severe, recurrent urinary tract or genital mycotic infections
* eGFR\<30mL/min/1.73m2 at time of or within 4 weeks of enrollment in the study
* Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.
* Language barrier, mental incapacity, unwillingness or inability to understand.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant.
* Currently or planning to take a SGLT2i prior to or during enrollment in the study
* Currently or planning to follow a ketogenic diet pattern ("keto diet) prior to or during enrollment in the study
* Currently or planning to follow an active weight loss program (including but not limited to use of supplements, medications, or surgery) prior to or during enrollment in the study
* Currently or planning to follow an intermittent fasting diet plan prior to or during enrollment in the study
* Currently or planning to take a GLP-1 receptor agonist prior to or during enrollment in the study .
* Existing lower limb ulcer (due to diabetes or any cause)
* Existing severe peripheral arterial disease with intermittent claudication and/or prior lower limb revascularization procedure
* Concomitant administration of UGT inducers
* Severe liver disease
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale New Haven Health — New Haven, Connecticut, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Henry K Yaggi, M.D. — Yale University
- Study coordinator: Henry K Yaggi, M.D.
- Email: henry.yaggi@yale.edu
- Phone: 203-785-4163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.