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

Study acronym: ADIPOSA
StatusRecruiting
PhasePhase 4
Started2024-03-27
View on ClinicalTrials.gov ↗

Amendment history

2026-08-25
3 amendments v7-v9
3 re-verifications since 2024-09-04, no change to tracked fields
2024-04-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02→confirmed 2024-03-27
Study sitesdetails revised at 2 of 2 sites
2024-02-01
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v5
Start date2024-01→2024-02
InterventionsErtugliflozin 15 mg (Drug), Placebo (Drug)→Bexagliflozin 20 mg (Drug), Placebo (Drug)
Eligibility criteria+883 characters
[...] 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 disor [...] of diabetic ketoacidosis Known hypersensitivity reaction to ertugliflozinbexagliflozin or any of its constituents or any contraindication to ertugliflozinbexagliflozin use Severe, recurrent urinary tract or genital mycotic infections PlaneGFR<30mL/min/1.73m2 toat initiatetime glucagon-like peptide 1 (GLP-1) receptor agonist therapy for weight lossof or glycemicwithin contr [...] [...]
Secondary endpoints26 to 27 entries
Change inThe Sleep Apnea Quality of Life Index (SAQLI).
Study descriptionrevised
The primary objective of this study is to determine whether ertugliflozinbexagliflozin 1520 mg once daily compared with placebo reduces the apnea hypop [...] secondary objectives of this study are to determine whether ertugliflozinbexagliflozin 1520 mg once daily compared with placebo (a look-alike substance [...] New Haven Health (YNHH). Participants will be randomized to ertugliflozinbexagliflozin 1520 mg once daily or matching placebo in addition to standard r [...]
2024-01-18
Study Status v4
Re-verified, no change to tracked fields
2023-07-31
Study Status v3
Start date2023-07→2024-01
Show 2 earlier versions
2023-06-12
Study Status v2
Start date2023-05→2023-07
2023-01-24
Study Status v1
Start date2022-11→2023-05
2022-11-03
Original filing
Yale University
487 trials monitored
See 35 trials at risk
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 Details
NCT Number NCT05612594
Lead Sponsor Yale University
Collaborators: Case Western Reserve University
Conditions Sleep Apnea
Enrollment 164 participants
Start Date 2024-03-27
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-27