Sleep; ApneaNCT02978937
Obstructive Sleep Apnea and Metabolic Health
An observational study of Sleep; Apnea and Metabolism Disorder, run by Ohio State University at 1 site in United States.
Trial summary
This is an observational study involving chart review of patients seen in the bariatric clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into two groups according to their metabolic profile (healthy vs unhealthy). Read more about this study
- Who is it for?
- Ages 21 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep; Apnea, Metabolism Disorder
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 15 Jan 2017
- 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 21 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include a representative sample of the patient population at OSU, which is 59% Caucasian, 39% African American, and the remainder of mixed, Asian, or Native American descent. The investigators will review outpatient data from subjects seen at OSU Wexner Medical Center for Minimally Invasive surgery. The individual cohorts will then be divided based on the presence of OSA and metabolic abnormalities.
Who may be able to join
- Age 21 - 88 year old
- BMI ≥ 30 kg/m2
Who cannot join
- Lack of pertinent clinical data to include in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstrutive Sleep Apnea: is it a Biomarker of Metabolically Healthy vs. Unhealthy Obese
This is an observational study involving chart review of patients seen in the bariatric clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into two groups according to their metabolic profile (healthy vs unhealthy). The assignment to each group will be determined by the presence of diagnosis of hypertension, diabetes mellitus and/or dyslipidemia. The presence of at least 2 diagnoses will be defined as metabolically unhealthy. Then, each group will be divided based on the presence of Obstructive Sleep Apnea diagnosis. All data will be collected through a review of the patient's electronic medical record from the bariatric clinic database (the investigators will collect variables as age, gender, race, BMI, smoking status, the presence of diagnosis as Obstructive sleep apnea, hypertension, diabetes, hyperlipidemia). The investigators will analyze that data and establish if there is any correlation between sleep apnea and the subjects' metabolic profile.
Read the detailed description
Obesity is associated with numerous metabolic complications including Type 2 diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease (CVD) and several forms of cancer. However, the presence of these obesity-related metabolic abnormalities varies among obese individuals. The phenotype of a metabolically healthy obese (MHO) individual was initially described in 1980 and includes a subset of obese patients (as defined by BMI) who do not manifest the typical metabolic abnormalities associated with obesity. Although results are conflicting and highly dependent on patient population and diagnostic criteria for metabolic health, these individuals tend to have a preserved level of insulin sensitivity, absence of hypertension, and a more favorable lipid, inflammatory, hormonal, hepatic, and immunologic profile compared to the majority of metabolically abnormal obese (MAO) patients. This seeming paradox underscores that excess body the weight is not the sole determinant of obesity-related complications and allows for novel pathogenic investigation.
The postulated mechanism(s) underlying the differential metabolic profile in these individuals is not well known and the physiologic and molecular basis for 'healthy' obesity remains relatively undiscovered. In addition, a recent meta-analysis demonstrated that although MHO patients have a comparable metabolic profile to normal the weight individuals, their risk of adverse, long-term CV and mortality outcomes remains higher, calling into question the clinical importance of the healthy obese categorization. Despite these knowledge gaps, a limited number of studies have recently attempted to elucidate the processes that lead to the MHO profile, including characterization of lifestyle factors, adipocyte size, amount and location of ectopic fat, inflammatory mediators, and immune cells, and differences in gene expression.
The prevalence of obstructive sleep apnea (OSA) increases with increasing BMI and has also been linked to various cardiometabolic abnormalities. Patients with OSA experience repetitive episodes of hypoxia and reoxygenation during transient cessation of breathing that may provoke adverse systemic effects. These effects are reflected in increased levels of biomarkers linked to endocrine-metabolic and cardiovascular disease. OSA may exert negative effects on the cardiovascular system through multiple mechanisms including hypoxemia, sleep disruption, activation of the sympathetic nervous system, and inflammatory activation. In spite of this connection, the contribution of these deleterious effects in determining the phenotype of an obese patient (MHO vs. MAO) is unknown. Furthermore, the prevalence of OSA in these two subsets is not the well established.
In this study, the investigators hypothesize the prevalence of OSA is higher in MAO compared to BMI-matched MAO patients
Aim 1:
Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients.
Aim 2:
Elucidate the association of OSA disease severity parameters with markers of clinically available abnormal metabolic profile (elevated cholesterol, blood pressure, fasting glucose/hemoglobin A1c, inflammatory markers, and insulin resistance if available).
- Conditions
- Sleep; Apnea, Metabolism Disorder
- Medical subject headings
- Sleep Apnea Syndromes, Metabolic Diseases
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 |
|---|---|---|
| Metabolically healthy and abnormal obese | Obese patients divided into two groups according to their metabolic profile (healthy vs unhealthy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients.
Measured: 2 years
Elucidate the association of OSA disease severity parameters with markers of clinically available abnormal metabolic profile
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startApr 2015
- Primary completionNov 2016
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep; ApneaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Bradley MD, Ohio State University
- Investigators
- David Bradley, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978937
- Sponsor's protocol ID
- 2015E0155
- Status last verified
- Jun 2017
- First submitted
- 29 Nov 2016
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Publications
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstrutive Sleep Apnea: is it a Biomarker of Metabolically Healthy vs. Unhealthy Obese
- ClinicalTrials.gov ID
- NCT02978937
- Acronym / sponsor ID
- 2015E0155
- Conditions
- Sleep; Apnea, Metabolism Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
This is an observational study involving chart review of patients seen in the bariatric clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into two groups according to their metabolic profile (healthy vs unhealthy). The assignment to each group will be determined by the presence of diagnosis of hypertension, diabetes mellitus and/or dyslipidemia. The presence of at least 2 diagnoses will be defined as metabolically unhealthy. Then, each group will be divided based on the presence of Obstructive Sleep Apnea diagnosis. All data will be collected through a review of the patient's electronic medical record from the bariatric clinic database (the investigators will collect variables as age, gender, race, BMI, smoking status, the presence of diagnosis as Obstructive sleep apnea, hypertension, diabetes, hyperlipidemia). The investigators will analyze that data and establish if there is any correlation between sleep apnea and the subjects' metabolic profile.
Detailed description
Obesity is associated with numerous metabolic complications including Type 2 diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease (CVD) and several forms of cancer. However, the presence of these obesity-related metabolic abnormalities varies among obese individuals. The phenotype of a metabolically healthy obese (MHO) individual was initially described in 1980 and includes a subset of obese patients (as defined by BMI) who do not manifest the typical metabolic abnormalities associated with obesity. Although results are conflicting and highly dependent on patient population and diagnostic criteria for metabolic health, these individuals tend to have a preserved level of insulin sensitivity, absence of hypertension, and a more favorable lipid, inflammatory, hormonal, hepatic, and immunologic profile compared to the majority of metabolically abnormal obese (MAO) patients. This seeming paradox underscores that excess body the weight is not the sole determinant of obesity-related complications and allows for novel pathogenic investigation.
The postulated mechanism(s) underlying the differential metabolic profile in these individuals is not well known and the physiologic and molecular basis for 'healthy' obesity remains relatively undiscovered. In addition, a recent meta-analysis demonstrated that although MHO patients have a comparable metabolic profile to normal the weight individuals, their risk of adverse, long-term CV and mortality outcomes remains higher, calling into question the clinical importance of the healthy obese categorization. Despite these knowledge gaps, a limited number of studies have recently attempted to elucidate the processes that lead to the MHO profile, including characterization of lifestyle factors, adipocyte size, amount and location of ectopic fat, inflammatory mediators, and immune cells, and differences in gene expression.
The prevalence of obstructive sleep apnea (OSA) increases with increasing BMI and has also been linked to various cardiometabolic abnormalities. Patients with OSA experience repetitive episodes of hypoxia and reoxygenation during transient cessation of breathing that may provoke adverse systemic effects. These effects are reflected in increased levels of biomarkers linked to endocrine-metabolic and cardiovascular disease. OSA may exert negative effects on the cardiovascular system through multiple mechanisms including hypoxemia, sleep disruption, activation of the sympathetic nervous system, and inflammatory activation. In spite of this connection, the contribution of these deleterious effects in determining the phenotype of an obese patient (MHO vs. MAO) is unknown. Furthermore, the prevalence of OSA in these two subsets is not the well established.
In this study, the investigators hypothesize the prevalence of OSA is higher in MAO compared to BMI-matched MAO patients
Aim 1:
Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients.
Aim 2:
Elucidate the association of OSA disease severity parameters with markers of clinically available abnormal metabolic profile (elevated cholesterol, blood pressure, fasting glucose/hemoglobin A1c, inflammatory markers, and insulin resistance if available).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolically healthy and abnormal obese | – | –Obese patients divided into two groups according to their metabolic profile (healthy vs unhealthy) |
Who may qualify
- Ages
- 21 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include a representative sample of the patient population at OSU, which is 59% Caucasian, 39% African American, and the remainder of mixed, Asian, or Native American descent. The investigators will review outpatient data from subjects seen at OSU Wexner Medical Center for Minimally Invasive surgery. The individual cohorts will then be divided based on the presence of OSA and metabolic abnormalities.
Key inclusion criteria (2 listed)
- Age 21 - 88 year old
- BMI ≥ 30 kg/m2
Key exclusion criteria (1 listed)
- Lack of pertinent clinical data to include in the study.
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
Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients.
Time frame: 2 years
Elucidate the association of OSA disease severity parameters with markers of clinically available abnormal metabolic profile
Time frame: 2 years
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 7 Jun 2017.
- Individual participant dataSharing planned: No. Publications
Related trials for Sleep; Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
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.
David Bradley principal investigator
Ohio State University
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 Sleep; Apnea and Metabolism Disorder, run by Ohio State University 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 2 inclusion and 1 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 7 Jun 2017. 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?
Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients. (time frame: 2 years). 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 7 Jun 2017.