Bexagliflozin for Obstructive Sleep Apnea in Overweight Adults
Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study
Recruiting
Phase 4Interventional Study
Sleep Apnea
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
164 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for adults who are overweight or obese and have moderate to severe obstructive sleep apnea. Participants will take either the drug bexagliflozin or a placebo for 6 months while receiving regular care.
I have been diagnosed with obstructive sleep apnea.
I can provide informed consent and follow study procedures.
You may not be able to join if
I have conditions not related to obstructive sleep apnea that affect my breathing while sleeping.
I use sleep-inducing medications.
I have Type 1 diabetes.
I have a history of diabetic ketoacidosis.
I am allergic to bexagliflozin.
I have severe urinary tract infections.
I cannot undergo an MRI.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 defic…
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.
Trial Locations
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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 me…
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
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