Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT05612594
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05612594
Study Brief:
Protocol Section:
NCT05612594