- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02978937
Obstructive Sleep Apnea and Metabolic Health
Obstrutive Sleep Apnea: is it a Biomarker of Metabolically Healthy vs. Unhealthy Obese
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 21 - 88 year old
- BMI ≥ 30 kg/m2
Exclusion Criteria:
◦ Lack of pertinent clinical data to include in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Metabolically healthy and abnormal obese
Obese patients divided into two groups according to their metabolic profile (healthy vs unhealthy)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients.
Time Frame: 2 years
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2 years
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Elucidate the association of OSA disease severity parameters with markers of clinically available abnormal metabolic profile
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Bradley, Ohio State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015E0155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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