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

Last updated: September 4, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

4

Condition

Sleep Apnea Syndromes

Sleep Disorders

Treatment

Ertugliflozin 15 mg

Placebo

Bexagliflozin 20 mg

Clinical Study ID

NCT05612594
2000033371
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to provide informed consent and stated willingness to comply with all studyprocedures 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 followingmethods: a. Polysomnography: AHI ≥15/hour sleep or b. Home sleep apnea testing: Respiratoryevent index (REI) ≥15/hour sleep

  • AHI: apnea-hypopnea index (apneas + hypopneas / total sleep time in hours)

Exclusion

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 pulmonarydisorder)

  • 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 anycontraindication 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 severeclaustrophobia or metallic implants.

  • Language barrier, mental incapacity, unwillingness or inability to understand.

  • Females of childbearing potential who are pregnant, breast-feeding or intend tobecome 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 orduring enrollment in the study

  • Currently or planning to follow an active weight loss program (including but notlimited to use of supplements, medications, or surgery) prior to or duringenrollment in the study

  • Currently or planning to follow an intermittent fasting diet plan prior to or duringenrollment in the study

  • Currently or planning to take a GLP-1 receptor agonist prior to or during enrollmentin the study .

  • Existing lower limb ulcer (due to diabetes or any cause)

  • Existing severe peripheral arterial disease with intermittent claudication and/orprior lower limb revascularization procedure

  • Concomitant administration of UGT inducers

  • Severe liver disease

Study Design

Total Participants: 164
Treatment Group(s): 3
Primary Treatment: Ertugliflozin 15 mg
Phase: 4
Study Start date:
March 27, 2024
Estimated Completion Date:
September 30, 2027

Study Description

The primary objective of this study is to determine whether bexagliflozin 20 mg once daily compared with placebo reduces the apnea hypopnea index (AHI) in adults with overweight or obesity with moderate to severe OSA.

The secondary objectives of this study are to determine whether bexagliflozin 20 mg once daily compared with placebo (a look-alike substance that contains no active drug):

  • reduces visceral and neck fat and upper airway soft tissue structure volumes and increases airway caliber

  • reduces Critical closing pressure

  • reduces rostral to caudal fluid shifts (measured by neck circumference)

  • improves clinical measures of OSA severity and sleep deficiency

This is a 2-center clinical trial of overweight or obese adults (BMI 25-40 kg/m2) diagnosed with moderate to severe OSA, recruited from University Hospitals Cleveland Medical Center (UH) and Yale New Haven Health (YNHH). Participants will be randomized to bexagliflozin 20 mg once daily or matching placebo in addition to standard routine clinical care for both groups for 6 months. At baseline and at study end, participants will undergo measurements of anatomic traits using MRI imaging, critical closing pressure, blood-based biomarkers of dysfunctional adiposity, non-anatomic physiologic trait polysomnographic phenotyping, morning neck circumference, clinical measures of sleep apnea severity (apnea hypopnea index (AHI), oxygen desaturation index (ODI), % time with O2sat < 90% (T90)), sleep arousal index (AI)), and measures of sleep deficiency, to evaluate the effects of SGLT2i on the measured phenotypes.

Connect with a study center

  • Yale New Haven Health

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

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