- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02130050
Metabolic Profiling in Patients With Obstructive Sleep Apnea: From Plasma to Hypoxic Cell Model of Peripheral Monocyte
April 30, 2014 updated by: National Taiwan University Hospital
This three-year project aims to
- Profile the differentially expressed metabolites in healthy patients with severe Obstructive sleep apnea (OSA) before and after six-month continuous positive airway pressure (CPAP) treatment
- Identify the candidate metabolites involved in biologic pathways attributing to OSA phenotyping and response to CPAP treatment
- Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes
Study Overview
Status
Unknown
Conditions
Detailed Description
Obstructive sleep apnea is characterized with chronic intermittent hypoxia and sleep fragmentations.
The sequels of OSA included excessive daytime sleepiness, cardiovascular disease, and neurocognitive dysfunction which could be reversed with continuous positive airway pressure (CPAP).
A couple of biologic pathways have been associated with the phenotyping of OSA which included craniofacial morphology, ventilator control, body fat distribution/metabolism, and sleepiness vulnerability.
Metabolomics, a recently developed technique to detect metabolomic profiles, could help to understand the disease pathophysiology and explore biomarkers.
So far, only one paper studied the metabolomic profile in patients with OSA where putative identifications of 14 statistically significant features were profiled.
Our pilot study comparing the metabolic profiling in OSA patients randomly assigned to therapeutic and subtherapeutic CPAP showed CPAP treatment did alter the metabolomic profile.
Seventeen metabolites in three biologic pathways and 13 metabolites in the six biologic pathways were identified in therapeutic and subtherapeutic CPAP, respectively.
Sixteen metabolites in three biologic pathways were identified by comparing two groups.
However, there were a couple of weakness in studies in the literature and ours.
Furthermore, the direct causal relationship of the profiled metabolites and OSA needs to be clarified.
Therefore, we plan to compare the metabolic profiling in control subjects and healthy OSA patients, before and after six-month CPAP treatment, to identify candidate metabolites involved in biologic pathways attributing to phenotyping and response to CPAP treatment.
Furthermore, candidate metabolites involved in biologic pathways, especially pathways of ROS, inflammation, and metabolism, will be validated in the intermittent hypoxia model of peripheral monocytes.
Study Type
Observational
Enrollment (Anticipated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
moderate to severe OSA from primary care clinic friends and families from recommendation of OSA patients
Description
OSA patients
Inclusion Criteria:
- male patients aged 20 to 90 year who have daytime sleepiness (ESS>=10)
- newly diagnosed OSA (AHI>30/hr) by overnight PSG but never been treated
Exclusion Criteria:
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
- enrolled in other trials in the study period
- other sleep disorders
- sleepy driver
- using maintenance medications
Control subjects
Inclusion Criteria:
- Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
- non-sleepy
- no OSA confirmed by home sleep study (AHI<5/hr)
Exclusion Criteria:
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
- enrolled in other trials in the study period
- other sleep disorders
- using maintenance medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
OSA Patient
•male patients aged 30 to 65 yr who are newly diagnosed as severe OSA (AHI >=30/hr)
|
Control subjects:
•male control subjects are recruited from Heath Check-up Center.
Subjects who are matched with OSA patients at age (+/-2 yrs), body height (+/-3cm) and body weight (<100 kg: +/-3kg, >100 kg: +/-4kg) are screened.
Only subjects who are not sleepy (ESS<10) and have no OSA (AHI<5/hr PSG)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The expressed metabolites profiles
Time Frame: 6 months
|
Profiling the differentially expressed metabolites in control subjects and healthy patients with severe OSA before and after six-month CPAP treatment
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolites in the intermittent-hypoxia model of peripheral monocytes
Time Frame: 6 months
|
Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peilin Lee, M.D., National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
April 1, 2015
Study Completion (Anticipated)
April 1, 2015
Study Registration Dates
First Submitted
April 11, 2014
First Submitted That Met QC Criteria
April 30, 2014
First Posted (Estimate)
May 2, 2014
Study Record Updates
Last Update Posted (Estimate)
May 2, 2014
Last Update Submitted That Met QC Criteria
April 30, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201401106RINB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
Morehouse School of MedicineNot yet recruiting
-
Yonsei UniversityRecruitingCardiovascular DiseaseKorea, Republic of
-
Nanjing Medical UniversityNot yet recruitingCardiovascular Disease
-
National Human Genome Research Institute (NHGRI)Active, not recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruiting
-
AmgenCompletedCardiovascular DiseaseUnited States, Australia
-
VA Office of Research and DevelopmentEnrolling by invitationCardiovascular DiseaseUnited States