Obstructive Sleep Apnea of AdultNCT03307330
A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea of Adult, run by Mayo Clinic at 1 site in United States.
Trial summary
Studies show that sleep apnea increases the risk of cardiovascular disease and is associated with obesity. However, it is unclear how sleep apnea affects fat tissue. Studies have shown that fat tissue is likely involved in developing cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with obstructive sleep apnea and healthy subjects without chronic diseases and interested in participating will be enrolled in this study.
Who may be able to join
- BMI ≤40 kg/m2
- Not a current smoker or tobacco user
- Individuals with treated hypertension, prehypertension, and dyslipidemia will be allowed to participate in the study
- On no prescription medications other than those medications used to treat asthma, seasonal or environmental allergies (such as Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), depression, acid reflux (such as antacids or proton pump inhibitors), topical skin treatment medications or shampoos, contraceptive pills, or intrauterine devices. Other medications may be allowed at the discretion of the study staff.
- Not pregnant or breast feeding and not intending to become pregnant or breast feed
- Ability to provide written informed consent
- If a subject is on aspirin or any other anti-inflammatory medication but free of known vascular disease and depending on the indication, the study doctor may ask the subject to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the study. In the event that the subject does not stop the aspirin or other anti-inflammatory medication, they will not be able to participate in the study because of the risk of bleeding during the fat biopsy.
Who cannot join
- Vulnerable study population will be excluded
- Presence of chronic kidney disease (creatinine >2.5 mg/dL) and/or active cancers
- Pregnancy
- Anemic (hemoglobin <12 g/dL for men and <11 g/dL for women)
- Smoking
- Use of chronic medications (statins, anti-inflammatory drugs, angiotensin II receptor blockers (ARBs) and/or angiotensin-converting enzyme (ACE) inhibitors)
- Blood or plasma donation during the past 2 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Somers_CPL LAB, 507-255-8794, CPLOSA@mayo.edu
Virend Somers, MD, Ph.D, 507-255-1144, somers.virend@mayo.edu
About this study
Studies show that sleep apnea increases the risk of cardiovascular disease and is associated with obesity. However, it is unclear how sleep apnea affects fat tissue. Studies have shown that fat tissue is likely involved in developing cardiovascular disease. The purpose of this study is to see how sleep apnea changes fat tissue.
Read the detailed description
In recent years, the contribution of adipose tissue to obesity-related insulin resistance (IR), diabetes mellitus and cardiovascular disease (CVD) has become clear.In particular, accumulation of damaged cells in obese and aging adipose tissue has been shown to impair adipose tissue function and may thus increase CVD risk. Cellular and molecular alterations in adipose tissue are known to contribute to adipose tissue and systemic insulin resistance, chronic inflammation, and may lead to higher blood pressure. Importantly, any clinical consequences of adipose tissue dysfunction would be compounded by the large amount, and central metabolic role, of adipose tissue in humans. However, there is a gap in our understanding of the OSA-induced changes in the adipose tissue and its implication for development of cardiometabolic disorders.
The aim of this study is to examine the cellular and molecular composition of adipose tissue in obstructive sleep apnea (OSA) subjects in comparison to adipose tissue from healthy individuals. We hypothesize that adipose tissue from OSA subjects will have a higher accumulation of markers of cellular damage with positive p16 and γH2AX. These studies will provide pivotal insights into pathways that may be targeted to reduce cardiometabolic burden in OSA population.
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive Sleep Apnea, Adipose Tissue
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) >=5 | |
| Non-Obstructive Sleep Apnea | Non-Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) < 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue
Positivity for both (p16^IND4A and γH2AX) serves as a marker of cellular damage. A fat biopsy from the abdomen and thigh will be performed to obtain up to 1 gm of adipose tissue from each site. These fat samples will be batched for analysis.
Measured: Day 2
Secondary outcomes (5)
Prevalence of phosphorylated p53 (pp53) in adipose tissue
Presence of pp53 as a ratio of phospho to total p53 to access cellular damage in adipose tissue.
Measured: Day 2
24- h mean arterial pressure
ambulatory measure of blood pressure in mmHg
Measured: Day 2
Vascular endothelial function
Change in Brachial artery diameter in response to hyperemia
Measured: Day 2
Insulin sensitivity
Oral glucose tolerance testing
Measured: Day 2
Body composition
Percentage body fat content
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start8 Jan 2018
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD., Ph.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307330
- Sponsor's protocol ID
- 17-003825
- Other IDs
- R01HL065176
- Status last verified
- Feb 2026
- First submitted
- 6 Oct 2017
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03307330
- Acronym / sponsor ID
- 17-003825
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive Sleep Apnea, Adipose Tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Oct 2017 (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.
Studies show that sleep apnea increases the risk of cardiovascular disease and is associated with obesity. However, it is unclear how sleep apnea affects fat tissue. Studies have shown that fat tissue is likely involved in developing cardiovascular disease. The purpose of this study is to see how sleep apnea changes fat tissue.
Detailed description
In recent years, the contribution of adipose tissue to obesity-related insulin resistance (IR), diabetes mellitus and cardiovascular disease (CVD) has become clear.In particular, accumulation of damaged cells in obese and aging adipose tissue has been shown to impair adipose tissue function and may thus increase CVD risk. Cellular and molecular alterations in adipose tissue are known to contribute to adipose tissue and systemic insulin resistance, chronic inflammation, and may lead to higher blood pressure. Importantly, any clinical consequences of adipose tissue dysfunction would be compounded by the large amount, and central metabolic role, of adipose tissue in humans. However, there is a gap in our understanding of the OSA-induced changes in the adipose tissue and its implication for development of cardiometabolic disorders.
The aim of this study is to examine the cellular and molecular composition of adipose tissue in obstructive sleep apnea (OSA) subjects in comparison to adipose tissue from healthy individuals. We hypothesize that adipose tissue from OSA subjects will have a higher accumulation of markers of cellular damage with positive p16 and γH2AX. These studies will provide pivotal insights into pathways that may be targeted to reduce cardiometabolic burden in OSA population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | –Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) >=5 |
| Non-Obstructive Sleep Apnea | – | –Non-Obstructive sleep apnea is defined as having Apnea hypopnea index (AHI) < 5 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with obstructive sleep apnea and healthy subjects without chronic diseases and interested in participating will be enrolled in this study.
Key inclusion criteria (7 listed)
- BMI ≤40 kg/m2
- Not a current smoker or tobacco user
- Individuals with treated hypertension, prehypertension, and dyslipidemia will be allowed to participate in the study
- On no prescription medications other than those medications used to treat asthma, seasonal or environmental allergies (such as Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), depression, acid reflux (such as antacids or proton pump inhibitors), topical skin treatment medications or shampoos, contraceptive pills, or intrauterine devices. Other medications may be allowed at the discretion of the study staff.
- Not pregnant or breast feeding and not intending to become pregnant or breast feed
Key exclusion criteria (7 listed)
- Vulnerable study population will be excluded
- Presence of chronic kidney disease (creatinine >2.5 mg/dL) and/or active cancers
- Pregnancy
- Anemic (hemoglobin <12 g/dL for men and <11 g/dL for women)
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue
Time frame: Day 2
Positivity for both (p16^IND4A and γH2AX) serves as a marker of cellular damage. A fat biopsy from the abdomen and thigh will be performed to obtain up to 1 gm of adipose tissue from each site. These fat samples will be batched for analysis.
5 secondary outcomes
Prevalence of phosphorylated p53 (pp53) in adipose tissue
Time frame: Day 2
24- h mean arterial pressure
Time frame: Day 2
Vascular endothelial function
Time frame: Day 2
Insulin sensitivity
Time frame: Day 2
Body composition
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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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.
Virend Somers, MD., Ph.D principal investigator
Mayo Clinic
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 of Adult, run by Mayo Clinic 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 7 inclusion and 7 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Somers_CPL Lab (507-255-8794, CPLOSA@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dual positive p16^IND4A and gamma H2AX cells in adipose tissue (time frame: Day 2). 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.