Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05123859 |
| Other study ID # |
21-2153 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2022 |
| Est. completion date |
August 14, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a registry to identify changes in the expression of aging-related biomarkers, changes
in functional performance, and/or changes in quality-of-life across the aging spectrum in 250
participants ≥ 25 years of age that will be conducted by the University of North Carolina.
The primary purpose of this registry is to measure biomarkers of aging/senescence and build
computational models of aging in order to better understand the role of senescence in
aging-related functional decline and differences between aging in a general population vs
cohorts enriched for aging related disease (cancer, heart disease). Aging biomarker data in
cohorts with cancer and heart disease has already been collected; the current study will
enroll participants into the cohort of aging in the general population (Aging Cohort).
Over the past century, life expectancy has increased by 30 years. With that gain has come a
dramatic rise in age-related disease and an urgent need to understand, prevent, and treat
these conditions. While age-related diseases have diverse phenotypes, there is increasing
recognition of common biological underpinnings with cellular senescence as the nexus linking
subcellular changes due to epigenetic changes, DNA damage, and mitochondria dysfunction with
a decline in health due to multi-morbidity. The molecular changes that shift one's aging
trajectory from a 'healthy' state to a 'disease' state are poorly understood; however, there
is increasing evidence that senescence plays a key role in this shift. Computational models
of natural aging and aging related disease are important tools in understanding the
phenomenon of senescence, its regulation and dynamics, and its role in physiological or
pathological processes during human aging. These findings will serve as pilot data for future
analysis of cellular senescence, as measured by p16INK4 (hereafter referred to as p16)
expression, and aging in other cohorts and begin to establish comparisons between p16 and
other potentially clinically relevant aging biomarkers such as DNA methylation and plasma
proteomics.
Description:
The primary purpose of this registry is to collect aging biomarker data in a general
population across the entire lifespan (Aging Cohort). The investigators will then build
several computational models of aging in order to better understand senescence in the context
of general aging or specific aging associate diseases. As a secondary goal, The investigators
will determine the association between biomarkers of aging and health characteristics
(defined through blood chemistry panels and specific functional measures). Central to these
computational models is the measurement of a biomarker of aging/senescence, p16INK4
(hereafter referred to as p16) in peripheral blood T cells. The primary aim of this registry
is to determine if p16 mRNA expression measured in T cells reflects total organismal
senescent load. The secondary aim is to determine if senescence dynamics are affected by
age-associated chronic diseases. The exploratory aim is to determine the ability of
computational models of senescence to predict clinical and functional status. Active
participation in the study will end at the completion of the study questionnaires and
assessments, but The investigators will ask permission to recontact participants at a later
date for longitudinal sample collection.
Despite the prominence of senescence as an aging mechanism and target of geroscience-based
therapies, little is known about the dynamics of senescent cells in humans. Understanding the
process of senescence, including its regulation, dynamics, and contribution to physiologic or
pathologic processes, is essential for an understanding of aging.
In this registry, the investigators will assess the contribution of senescence,
co-morbidities, functional performance, and quality of life to aging. The investigators will
determine the ability of these factors to aid in the development of a new stochastic model
that will be formulated specifically in the context of T-cell turnover and senescence,
thereby providing a cell level description of p16 accumulation and a mechanistic model with
parameters characterizing relevant physiological processes. The development of this new model
will thus enable a quantitative, predictive, mechanistic study of the role of senescence in
aging at both organismal and cellular levels
