NCT01694342

Brief Summary

Telomerase, through its regulatory function on telomere length may play an important role in immune function, cellular replicative life span, and carcinogenesis. Non-alcoholic fatty liver disease (NAFLD) is considered a benign condition, but in some cases, it may progress to cirrhosis and hepatocellular carcinoma. The risk factors for that evolution are not fully understood. Our group showed in a previous study, that hTERT mRNA expression is lower in peripheral lymphocytes of patients with fatty liver, compared to healthy controls. This finding could explain the telomere shortening found previously in these patients by our group \[20\] and others \[21\]. Furthermore, we found higher rates of TC in these patients, probably due to an attempt to counteract the shortening of the telomeres and to stabilize them. This is through a different mechanism that is not telomerase-mediated. Telomere capture is considered an alternative way to maintain telomere length and chromosomal stability \[3\]. It is a more common mechanism for chromosome stabilization and repair, in contrast to the telomerase-mediated process of chromosome healing and elongation This study aimed to evaluate mechanisms of telomere homeostasis like telomere shortening, telomerase activity, telomere capture and aneuploidy in patients with NAFLD in order to explain previous findings of telomere shortening in these patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
Last Updated

September 27, 2012

Status Verified

July 1, 2012

First QC Date

September 23, 2012

Last Update Submit

September 26, 2012

Conditions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals - over 18 years old that were diagnosed with nonalcoholic fatty liver and are on follow-up in our liver unit

You may qualify if:

  • age over 18
  • diagnosis of fatty liver

You may not qualify if:

  • no malignancy
  • no eligible to sign the consent paper

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Hospital

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Central Study Contacts

Yona Kitay-Cohen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2012

First Posted

September 27, 2012

Study Start

September 1, 2012

Last Updated

September 27, 2012

Record last verified: 2012-07

Locations