Viewing Study NCT00242255



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Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00242255
Status: COMPLETED
Last Update Posted: 2021-02-09
First Post: 2005-10-19

Brief Title: Epigenetics in the Aging Process
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Remodeling of Chromatin-Based Epigenetic Structures in Development and Aging
Status: COMPLETED
Status Verified Date: 2021-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will examine the role of epigenetics heritable changes in gene function that occur without a change in DNA sequence in the aging process DNA is the primary genetic material responsible for transmitting information from one cell to the next or from one generation to the next A second layer of heredity is described by the term epigenetics

Epigenetic information is reset from one generation to the next It works in two ways 1 by modification of the DNA like balloons stuck at irregular intervals onto the sides of the DNA helix that encodes genes and 2 through specialized protein shells that wrap around some regions of DNA As in DNA these shells can copy themselves and can transmit instructions Because they are used to turn genes on and off errors in their settings cause critical misinformation to be transmitted

Aging involves many changes such as muscle weakening graying hair skin wrinkling and so forth There are several current theories of aging including damage to genes by oxidation shortening of tiny structures at the ends of chromosomes called telomeres and the ability to stretch lifespan with caloric restrictions This study will investigate the possible role of epigenetics in aging by examining and comparing the shell-like epigenetic settings in skin cells in young adults and older individuals Preliminary results from earlier studies show differences in these settings in younger and older people

Women between the ages of 21 and 30 years and 65 and 90 years who are undergoing breast reduction or mastectomy at Suburban Hospital in Bethesda Maryland may participate in this study Tissue removed during surgery for pathological examination will also be used by researchers in this study to validate the preliminary findings noted above and to continue studies into the new area of epigenetics and aging

Detailed Description: Normal human lifespan is marked by a complex series of developmental events relative stability during adulthood and ultimately a gradual decline in viability Biological clocks presumably underlie the developmental events that occur through childhood and adolescence but the nature of those clocks has remained obscure Progress in this area would be of considerable importance not only for our understanding of child development but also because instability in putative clock-like mechanisms may occur as part of the aging process Such instability could well compromise tissue function and contribute to many of the common degenerative diseases of later life We propose to investigate whether developmental clocks and related aspects of the aging process are attributable in part to age-related epigenome remodeling Experiments done to date with cultured human fibroblasts derived from tissue banks provide tentative support for this hypothesis To exclude tissue culture-related artifacts and to continue the work it is essential to have access to fresh tissue material in the form of surgically obtained skin specimens that would otherwise be discarded Elective breast reduction mammoplasty is a frequently performed surgery at Suburban Hospital Bethesda Maryland Small skin specimens will be obtained from this procedure as well as from normal skin derived from mastectomies Patients who are to undergo these procedures will be asked to sign a consent form allowing the specimens normally discarded to be used instead for research on the mechanism of aging They will be informed that clinical information will accompany the specimens including age and known disease conditions Twenty patients in each of two age ranges 21-30 yr and 65-90 yr will be enrolled in the study The primary outcome will be confirmation of age-related epigenome change in the chromosome 4q352 region previously documented using tissue bank-derived cultured skin fibroblasts Mapping and sampling chromatin from this region revealed higher histone H4 acetylation in young 24-30 yr than old 80-85 yr individuals Confirmation of this change in primary fibroblasts will be followed by more detailed mapping of chromatin structure and extension beyond the currently defined limits Secondary outcomes will include examination of two areas of epigenome remodeling that appear to occur between birth and adulthood as well as searches for additional regions of age-related chromatin change

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
06-CH-0010 None None None