Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia

Completed

Conditions studied: Obstructive Sleep Apnea, Hypoxia, Insulin Resistance

In brief

Obstructive sleep apnea (OSA) is a common condition associated with significant adverse health outcomes. Our overarching hypothesis is that patients with OSA and hypoxia (H-OSA) have greater degrees of insulin resistance in both liver and adipose tissue when compared to those without hypoxia (NH-OSA) thus leading to increased risk for the development of diabetes in the former group.

Key facts

Study ID

NCT03695315

Run by

University of California, San Francisco

People needed

48

Starts

2018-10-31

Expected to finish

2024-12-31

Last updated by the study team

2026-02-13

Who can join

Age: 19 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >19 years
• BMI >18.5 kg/m2
• Participants newly diagnosed obstructive sleep apnea (OSA) must meet the criteria for one of the two following groups:
• OSA with hypoxia (H-OSA) defined as those with an H-Apnea Hypopnea Index (AHI) ≥15 so as to match the NH-OSA subjects in event frequency and because this is the range defined as more than mild OSA such that we would be likely to see pathology associated with OSA; or,
• OSA without hypoxia (NH-OSA) defined as having a rate of non-hypoxic respiratory events ≥ 15 per hour (NH-AHI≥15) and having a rate of hypoxic events of less than 5 per hour (H-AHI<5,(52)).

You may not qualify if…

• Type 1 or 2 diabetes mellitus currently being treated with medications
• History of chronic obstructive pulmonary disease (COPD) or parenchymal lung disease
• Unstable hypertension
• Treatment for asthma (dependent on type of treatment)
• Current alcohol consumption exceeding 1 drink/day in women and 2 in men
• HIV infection
• Infectious hepatitis
• Pregnancy or lactation within the past six months
• Irregular use of any hypolipidemic agent
• History of surgery for obesity
• Hgb below the lower limit of normal
• Aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times the upper limit of normal
• Change in body weight >5% within preceding 3 months (by self-report)

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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