Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia
2 other identifiers
observational
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 13, 2026
February 1, 2026
6.2 years
October 2, 2018
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fractional De Novo Lipogenesis (DNL, %)
The percent of newly synthesized fatty acids (DNL, %) will be measured using a stable isotope (deuterated water) and mass spectrometry.
8 weeks
Liver fat Fraction (%)
Magnetic resonance will be used to measure liver and pancreatic fat fraction (%)
8 weeks
Secondary Outcomes (2)
Insulin secretion rate (picomol/min)
8 weeks
Total fat mass (grams)
8 weeks
Study Arms (2)
OSA with hypoxia
People with obstructive sleep apnea and hypoxia before and after treatment with continuous positive airway pressure
OSA without hypoxia
People with obstructive sleep apnea and without hypoxia before and after treatment with continuous positive airway pressure
Interventions
CPAP is a noninvasive treatment for sleep apnea
Eligibility Criteria
Participants will be recruited from the UCSF Clinical Sleep Medicine Laboratory. Patients seen by UCSF sleep medicine physicians (including Dr. Krystal \[Lab Co-Director\]) in sleep clinic and those who are referred for polysomnography (PSG) for OSA and for whom the physician has provided approval to be approached, will be contacted by the study coordinator and offered the opportunity to be screened to participate in the study. The study coordinator will review the consent form with the prospective volunteers and will ask for their approval to have their PSG data reviewed by Dr. Krystal, who will determine if the participants meet PSG entry criteria for participation in the study and if found to qualify, to be contacted by phone.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94110, United States
Biospecimen
Participation for genetic material retention is optional. Genetic information may be shared broadly in a coded form for future genetic research or analysis. This genetic information will NOT be used for genomic data sharing with genome-wide association studies. The genetic analysis which will be limited to the set of participants recruited to this study. The specimens may be used by our University of California, San Francisco (UCSF) research team for studies on diabetes, cardiovascular disease, liver disease, and other aspects of metabolism.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marc Schwarz, PhD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Andrew Krystal, MD
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2018
First Posted
October 4, 2018
Study Start
October 31, 2018
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share