Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia (NCT03695315) | Clinical Trial Compass
CompletedNot Applicable
Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia
United States48 participantsStarted 2018-10-31
Plain-language summary
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.
Who can participate
Age range19 Years – 100 Years
SexALL
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Sixty nondiabetic men and women
Inclusion Criteria:
* 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)).
Exclusion Criteria:
* 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)