deltatrials
Active Not Recruiting INTERVENTIONAL NCT04234217

Mechanisms of Prediabetic States in Sleep Apnea

Sponsor: AdventHealth

Updated 11 times since 2020 Last updated: Apr 23, 2026 Started: Nov 26, 2019 Primary completion: Jul 15, 2026 Completion: Jul 15, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04234217, this observational or N/A phase trial focuses on Pre-diabetes and Sleep Apnea and remains ongoing. Sponsored by AdventHealth, it has been updated 11 times since 2019, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.

Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.

Status Flow

~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshotRecruiting~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshotRecruiting~Jan 2021 – ~May 2022 · 16 months · monthly snapshotRecruiting~May 2022 – ~Apr 2023 · 11 months · monthly snapshotRecruiting~Apr 2023 – ~Jun 2024 · 14 months · monthly snapshotRecruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshotRecruiting~Jun 2025 – ~Dec 2025 · 6 months · monthly snapshotRecruiting~Dec 2025 – ~Apr 2026 · 5 months · monthly snapshotRecruitingApr 28, 2026 – present · 3 months · daily APIActive Not Recruiting

Change History

11 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting · Phase: NANone

  2. Dec 2025 — Apr 2026 [monthly]

    Recruiting NA

  3. Jun 2025 — Dec 2025 [monthly]

    Recruiting NA

  4. Sep 2024 — Jun 2025 [monthly]

    Recruiting NA

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

Show 6 earlier versions
  1. Jun 2024 — Jul 2024 [monthly]

    Recruiting NA

  2. Apr 2023 — Jun 2024 [monthly]

    Recruiting NA

  3. May 2022 — Apr 2023 [monthly]

    Recruiting NA

  4. Jan 2021 — May 2022 [monthly]

    Recruiting NA

  5. Jun 2020 — Jan 2021 [monthly]

    Recruiting NA

  6. Feb 2020 — Jun 2020 [monthly]

    Recruiting NA

    First recorded

Nov 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.

Contact Information

Sponsor contact:
  • AdventHealth
  • Mayo Clinic
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Chicago
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations