FATTY LIVERtelomereFLNCT01694342
Telomere Parameters in Patients With Nonalcoholic Fatty Liver
An observational study of FATTY LIVER and NO MALIGNANCY, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- FATTY LIVER, NO MALIGNANCY, NO DECOMPENSATED ILLNESS
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals - over 18 years old that were diagnosed with nonalcoholic fatty liver and are on follow-up in our liver unit
Who may be able to join
- age over 18
- diagnosis of fatty liver
Who cannot join
- no malignancy
- no eligible to sign the consent paper
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Hospital
Kfar Saba
Yona Kitay-Cohen, MD, +97297471560, yonaki@clalit.org.il
Yona Kitay-Cohen, MD
About this study
Official title: Telomere Parameters Like Telomere Length, Telomerase Expression, Telomere Capture and Aneuploidy in Patients With Nonalcoholic Fatty Liver
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.
- Conditions
- FATTY LIVER, NO MALIGNANCY, NO DECOMPENSATED ILLNESS
- Medical subject headings
- Fatty Liver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FATTY LIVERStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694342
- Sponsor's protocol ID
- ramona 1.0
- Acronym
- telomereFL
- Status last verified
- Jul 2012
- First submitted
- 23 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telomere Parameters Like Telomere Length, Telomerase Expression, Telomere Capture and Aneuploidy in Patients With Nonalcoholic Fatty Liver
- ClinicalTrials.gov ID
- NCT01694342
- Acronym / sponsor ID
- telomereFL / ramona 1.0
- Conditions
- FATTY LIVER, NO MALIGNANCY, NO DECOMPENSATED ILLNESS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals - over 18 years old that were diagnosed with nonalcoholic fatty liver and are on follow-up in our liver unit
Key inclusion criteria (2 listed)
- age over 18
- diagnosis of fatty liver
Key exclusion criteria (2 listed)
- no malignancy
- no eligible to sign the consent paper
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FATTY LIVER and NO MALIGNANCY, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yona Kitay-Cohen, MD (+97297471560, yonaki@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.