RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-03-27
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05612594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide informed consent and stated willingness to comply with all study procedures and availability for the duration of the study
  2. * Overweight or obese (body mass index 25-40 kg/m2)
  3. * Clinically confirmed diagnosis of obstructive sleep apnea by one of the following methods:
  4. * AHI: apnea-hypopnea index (apneas + hypopneas / total sleep time in hours)
  1. * Known non-OSA related conditions associated with sleep disordered breathing (e.g., central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder)
  2. * Use of sleep-inducing medications (e.g. benzodiazepines, opiates, barbiturates)
  3. * Type 1 diabetes mellitus
  4. * History of diabetic ketoacidosis
  5. * Known hypersensitivity reaction to bexagliflozin or any of its constituents or any contraindication to bexagliflozin use
  6. * Severe, recurrent urinary tract or genital mycotic infections
  7. * eGFR\<30mL/min/1.73m2 at time of or within 4 weeks of enrollment in the study
  8. * Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.
  9. * Language barrier, mental incapacity, unwillingness or inability to understand.
  10. * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant.
  11. * Currently or planning to take a SGLT2i prior to or during enrollment in the study
  12. * Currently or planning to follow a ketogenic diet pattern ("keto diet) prior to or during enrollment in the study
  13. * 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
  14. * Currently or planning to follow an intermittent fasting diet plan prior to or during enrollment in the study
  15. * Currently or planning to take a GLP-1 receptor agonist prior to or during enrollment in the study .
  16. * Existing lower limb ulcer (due to diabetes or any cause)
  17. * Existing severe peripheral arterial disease with intermittent claudication and/or prior lower limb revascularization procedure
  18. * Concomitant administration of UGT inducers
  19. * Severe liver disease

Contacts and Locations

Study Contact

Henry K Yaggi, M.D.
CONTACT
203-785-4163
henry.yaggi@yale.edu
Ian J Neeland, M.D.
CONTACT
216-844-5965
Ian.Neeland@UHhospitals.org

Principal Investigator

Henry K Yaggi, M.D.
PRINCIPAL_INVESTIGATOR
Yale University
Ian J Neeland, M.D.
PRINCIPAL_INVESTIGATOR
Case Western Reserve University School of Medicine

Study Locations (Sites)

Yale New Haven Health
New Haven, Connecticut, 06520
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Yale University

  • Henry K Yaggi, M.D., PRINCIPAL_INVESTIGATOR, Yale University
  • Ian J Neeland, M.D., PRINCIPAL_INVESTIGATOR, Case Western Reserve University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-27
Study Completion Date2027-09

Study Record Updates

Study Start Date2024-03-27
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep Apnea