A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT03307330|
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : January 21, 2019
|Condition or disease|
|Obstructive Sleep Apnea of Adult|
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 Type :||Observational|
|Estimated Enrollment :||135 participants|
|Official Title:||A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||July 1, 2023|
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
- 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.
- Prevalence of phosphorylated p53 (pp53) in adipose tissue [ Time Frame: Day 2 ]Presence of pp53 as a ratio of phospho to total p53 to access cellular damage in adipose tissue.
- 24- h mean arterial pressure [ Time Frame: Day 2 ]ambulatory measure of blood pressure in mmHg
- Vascular endothelial function [ Time Frame: Day 2 ]Change in Brachial artery diameter in response to hyperemia
- Insulin sensitivity [ Time Frame: Day 2 ]Oral glucose tolerance testing
- Body composition [ Time Frame: Day 1 ]Percentage body fat content
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307330
|Contact: Somers_CPL Lab||507-255-8794||CPLOSA@mayo.edu|
|Contact: Virend Somers, MD., Ph.Demail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Contact: Somers_CPL LAB 507-255-8794 CPLOSA@mayo.edu|
|Contact: Virend Somers, MD, Ph.D 507-255-1144 firstname.lastname@example.org|
|Principal Investigator:||Virend Somers, MD., Ph.D||Mayo Clinic|
|Principal Investigator:||Prachi Singh, Ph.D.||Mayo Clinic|