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RECRUITING

NCT05612594

PHASE4

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

Sponsor: Yale University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2024-03-27

Completion Date

2027-09

Last Updated

2025-09-11

Healthy Volunteers

Conditions

Sleep Apnea

Interventions

DRUG

Bexagliflozin 20 mg

15mg once daily

DRUG

Placebo

matching placebo once daily

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

Locations (2)

Yale New Haven Health

New Haven, Connecticut, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States