Obstructive Sleep ApneaNCT03695315
Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia
An observational study of Obstructive Sleep Apnea and Hypoxia, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypoxia, Insulin Resistance
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)).
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94110
About this study
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.
Read the detailed description
Obstructive sleep apnea (OSA) is a common condition associated with significant adverse health outcomes. An estimated 25% of men and 10% of women will have OSA during their lifetime. OSA is associated with an increased prevalence of insulin resistance and type 2 diabetes and, with severe degrees of OSA, non-alcoholic fatty liver disease (NAFLD) as well. The mechanisms accounting for the association between insulin resistance and OSA are not fully understood. We have previously demonstrated that experimentally induced sleep restriction in healthy volunteers led to a reduction in whole-body insulin sensitivity and increased rates of lipolysis and gluconeogenesis, accompanied by an increase in stress hormone levels. Studies by others suggest that, in animal models studied under hypoxic conditions, hepatic carbohydrate and lipid homeostasis are perturbed leading to hepatic steatosis and inflammation. Taken together, these observations form the basis of our overarching hypothesis 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. This hypothesis is based on the supposition that in NH-OSA insulin resistance is primarily triggered by increased levels of stress hormones due to fragmented sleep and this is manifested largely in extra-hepatic tissues (muscle and adipose), whereas in H-OSA there is additional stimulation of hepatic de novo lipogenesis, leading to liver fat accumulation and hepatic insulin resistance. The major goals of this project are to test our hypothesis and determine the impact of standard therapy for this condition, continuous positive airway pressure (CPAP), on insulin sensitivity. This will be achieved by addressing the following two specific aims.
In Aim 1 we will test the hypothesis that, although individuals with OSA have been shown to have insulin resistance in multiple target tissues (adipose, muscle, liver, beta cell), these abnormalities will be significantly greater in patients with OSA that is accompanied by hypoxia (H-OSA,) in comparison to those without hypoxia (NH-OSA). We will compare tissue-specific insulin sensitivity in 30 subjects with H-OSA and 30 with NH-OSA matched for sex, age, BMI, and apnea-hypopnea index. Hepatic and extra-hepatic insulin sensitivity will be measured using orally administered deuterated water stable isotope tracer studies of de novo lipogenesis and gluconeogenesis, both under fasting conditions and during oral glucose tolerance testing (OGTT). Lipolysis will be estimated via free fatty acid concentrations and mathematical modeling. Beta cell function and insulin kinetics will be assessed from insulin and C-peptide concentrations measured during the OGTT. Liver and pancreatic fat will be measured by magnetic resonance and total lean and fat mass by dual-energy X-ray absorptiometry.
In Aim 2 we will test the hypothesis that treatment with continuous positive airway pressure (CPAP) will improve insulin sensitivity in each of the target tissues and that these improvements will be greater in those with a greater number of OSA events per hour associated with hypoxia at baseline. Approximately 12 weeks after initiating CPAP therapy, each participant will undergo a follow-up sleep apnea test and metabolic assessments identical to those described above in Aim 1.
- Conditions
- Obstructive Sleep Apnea, Hypoxia, Insulin Resistance
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Obstructive Sleep Apnea, Hypoxia, Insulin Resistance
- Medical subject headings
- Sleep Apnea, Obstructive, Hypoxia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
CPAP is a noninvasive treatment for sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| OSA with hypoxia | People with obstructive sleep apnea and hypoxia before and after treatment with continuous positive airway pressure Receives: Device: Continuous Positive Airway Pressure | |
| OSA without hypoxia | People with obstructive sleep apnea and without hypoxia before and after treatment with continuous positive airway pressure Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Liver fat Fraction (%)
Magnetic resonance will be used to measure liver and pancreatic fat fraction (%)
Measured: 8 weeks
Secondary outcomes (2)
Insulin secretion rate (picomol/min)
Oral Glucose Tolerance Test is used to measure of insulin secretion rate
Measured: 8 weeks
Total fat mass (grams)
Dual energy x-ray absorptiometry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start31 Oct 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Schwarz, PhD, Principal investigator, University of California, San FranciscoAndrew Krystal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695315
- Sponsor's protocol ID
- 1R01DK117953
- Other IDs
- R01DK117953
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2018
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia
- ClinicalTrials.gov ID
- NCT03695315
- Acronym / sponsor ID
- 1R01DK117953
- Conditions
- Obstructive Sleep Apnea, Hypoxia, Insulin Resistance
- Keywords
- Obstructive Sleep Apnea, Hypoxia, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obstructive sleep apnea (OSA) is a common condition associated with significant adverse health outcomes. An estimated 25% of men and 10% of women will have OSA during their lifetime. OSA is associated with an increased prevalence of insulin resistance and type 2 diabetes and, with severe degrees of OSA, non-alcoholic fatty liver disease (NAFLD) as well. The mechanisms accounting for the association between insulin resistance and OSA are not fully understood. We have previously demonstrated that experimentally induced sleep restriction in healthy volunteers led to a reduction in whole-body insulin sensitivity and increased rates of lipolysis and gluconeogenesis, accompanied by an increase in stress hormone levels. Studies by others suggest that, in animal models studied under hypoxic conditions, hepatic carbohydrate and lipid homeostasis are perturbed leading to hepatic steatosis and inflammation. Taken together, these observations form the basis of our overarching hypothesis 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. This hypothesis is based on the supposition that in NH-OSA insulin resistance is primarily triggered by increased levels of stress hormones due to fragmented sleep and this is manifested largely in extra-hepatic tissues (muscle and adipose), whereas in H-OSA there is additional stimulation of hepatic de novo lipogenesis, leading to liver fat accumulation and hepatic insulin resistance. The major goals of this project are to test our hypothesis and determine the impact of standard therapy for this condition, continuous positive airway pressure (CPAP), on insulin sensitivity. This will be achieved by addressing the following two specific aims.
In Aim 1 we will test the hypothesis that, although individuals with OSA have been shown to have insulin resistance in multiple target tissues (adipose, muscle, liver, beta cell), these abnormalities will be significantly greater in patients with OSA that is accompanied by hypoxia (H-OSA,) in comparison to those without hypoxia (NH-OSA). We will compare tissue-specific insulin sensitivity in 30 subjects with H-OSA and 30 with NH-OSA matched for sex, age, BMI, and apnea-hypopnea index. Hepatic and extra-hepatic insulin sensitivity will be measured using orally administered deuterated water stable isotope tracer studies of de novo lipogenesis and gluconeogenesis, both under fasting conditions and during oral glucose tolerance testing (OGTT). Lipolysis will be estimated via free fatty acid concentrations and mathematical modeling. Beta cell function and insulin kinetics will be assessed from insulin and C-peptide concentrations measured during the OGTT. Liver and pancreatic fat will be measured by magnetic resonance and total lean and fat mass by dual-energy X-ray absorptiometry.
In Aim 2 we will test the hypothesis that treatment with continuous positive airway pressure (CPAP) will improve insulin sensitivity in each of the target tissues and that these improvements will be greater in those with a greater number of OSA events per hour associated with hypoxia at baseline. Approximately 12 weeks after initiating CPAP therapy, each participant will undergo a follow-up sleep apnea test and metabolic assessments identical to those described above in Aim 1.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA with hypoxia | – | Device: Continuous Positive Airway PressurePeople with obstructive sleep apnea and hypoxia before and after treatment with continuous positive airway pressure |
| OSA without hypoxia | – | Device: Continuous Positive Airway PressurePeople with obstructive sleep apnea and without hypoxia before and after treatment with continuous positive airway pressure |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureCPAP is a noninvasive treatment for sleep apnea | Device | OSA with hypoxia, OSA without hypoxia |
Primary outcome
Fractional De Novo Lipogenesis (DNL, %)
Time frame: 8 weeks
The percent of newly synthesized fatty acids (DNL, %) will be measured using a stable isotope (deuterated water) and mass spectrometry.
Liver fat Fraction (%)
Time frame: 8 weeks
Magnetic resonance will be used to measure liver and pancreatic fat fraction (%)
2 secondary outcomes
Insulin secretion rate (picomol/min)
Time frame: 8 weeks
Total fat mass (grams)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc Schwarz, PhD principal investigator
University of California, San Francisco
Andrew Krystal, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Hypoxia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional De Novo Lipogenesis (DNL, %) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.