Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05612594

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

Led by Yale University · Updated on 2025-09-11

164

Participants Needed

2

Research Sites

179 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent and willing to follow all study procedures and be available for the duration of the study
  • Overweight or obese with a body mass index between 25 and 40 kg/m2
  • Clinically confirmed diagnosis of obstructive sleep apnea by polysomnography with apnea hypopnea index (AHI) of 15 or more per hour or home sleep apnea testing with respiratory event index (REI) of 15 or more per hour
Not Eligible

You will not qualify if you...

  • Known non-OSA sleep breathing disorders such as central hypersomnolence, neurological, neuromuscular, or lung disorders
  • Use of sleep-inducing medications like benzodiazepines, opiates, or barbiturates
  • Diagnosis of type 1 diabetes mellitus
  • History of diabetic ketoacidosis
  • Known allergy or contraindication to bexagliflozin
  • Severe or recurrent urinary or genital infections
  • Kidney function with eGFR less than 30 mL/min/1.73m2 at or within 4 weeks before enrollment
  • Inability to tolerate MRI due to severe claustrophobia or metal implants
  • Language barriers or mental incapacity preventing study understanding
  • 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 during the study
  • Existing lower limb ulcers or severe peripheral arterial disease with claudication or prior limb revascularization
  • Use of UGT inducers
  • Severe liver disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

H

Henry K Yaggi, M.D.

CONTACT

I

Ian J Neeland, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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