AzTrials
AzTrials

Liver CirrhosisNCT01389115

Fatty Acids Lipidome and Oxidative Stress in Liver Transplantation

An observational study of Liver Cirrhosis, run by University of Roma La Sapienza at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to determine lipid metabolism in chronic liver disease in the attempt to find a useful biomarker of liver function and of prognostic value of graft function in those patients who undergo liver transplant. Read more about this study

Who is it for?
Ages 15 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Liver Cirrhosis
How many people
320 participants
Where
3 sitesItaly
Study dates
Jul 2001to Sep 2016
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 15 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 1. 150 cirrhotic patients, including Hepatocellular Carcinoma (HCC), Hepatitis C Virus (HCV) positive patients 2. 80 healthy controls 3. 100 liver donors

Liver cirrhosis inclusion criteria:

  • subjects with liver cirrhosis eligible for liver transplant, and one MELD score determination performed at least 3 months before liver transplantation

Liver cirrhosis exclusion criteria:

  • liver transplant contraindication and re-transplantation
  • current use of antioxidants and fatty acids supplements

Healthy controls are recruited recruited among the University personnel, after a review of their medical history.

Exclusion criteria for control participants included the use of drugs that affect fatty acids (systemic corticosteroids, isotretinoin, and ursodiol) and/or oxidative stress (antioxidants and hypolipemic drugs).

Trial locations and contacts

3 sites in 1 country.

Stefano Corradini, M.D., Ph.D. contact

+390649972086

stefano.corradini@uniroma1.it

Italy3 sites, 3 recruiting

  • Laboratory of Vascular Medicine, Department of Medical Sciences and Biotechnology, Sapienza University of Rome

    Latina, 04100

    Luigi Iuliano, M.D., +39 0773 471046, luigi.iuliano@uniroma1.it

    Chiara Zerbinati, Ph.D., +39 0773 471046, chiara.zerbinati@gmail.com

    Recruiting

  • Department of Clinical Medicine Division of Gastroenterology, Sapienza University of Rome

    Rome, RM, 00161

    Stefano Corradini, M.D., Ph.D., +39 06 4997 ext. 2086, Stefano.Corradini@uniroma1.it

    Antonio Molinaro, M.D., +39 06 4997 ext. 2086, antoniomolinaro83@libero.it

    Recruiting

  • Liver Transplant Center Paride Stefanini, Sapienza University of Rome

    Rome, RM, 00161

    Massimo Rossi, M.D., +39 3346214536, massimo.rossi@uniroma1.it

    Recruiting

Other trials in Italy

About this study

Official title: Fatty Acids Lipidome and Oxidative Stress Markers as Indicators of Liver Transplant Outcome

The purpose of this study is to determine lipid metabolism in chronic liver disease in the attempt to find a useful biomarker of liver function and of prognostic value of graft function in those patients who undergo liver transplant. The present study enrolls subjects with liver cirrhosis (with different ethiology), including subjects eligible for a full-size liver transplantation, and healthy controls.

Read the detailed description

Liver has a central role in fatty acids metabolism that is impaired in chronic liver diseases. Polyunsaturated fatty acids are reportedly reduced in liver cirrhosis, which is considered a condition of essential fatty acids deficiency. However, there is a paucity of data concerning the level of the multitude of circulating fatty acids in liver cirrhosis. Oxidative stress is involved in the pathogenesis of chronic liver disease and fibrosis. Increased oxidative stress with impaired antioxidant status at the systemic level has been described in different chronic liver diseases and negatively influences graft function after liver transplantation (Poli G. 2000, Loguercio C 2003). 7-Ketocholesterol and 7beta-hydroxycholesterol, prototype molecules of free radical-mediated cholesterol oxidation, are very important oxysterols currently accepted as in vivo reliable markers of oxidative stress. High oxysterols plasma levels are associated with an alteration of normal plasma fatty acid pattern in cystic fibrosis (Iuliano 2009). The Model for End-Stage Liver Disease (MELD) score is a common score used routinely to stage liver function in patients with liver cirrhosis (Al Sibae 2010). After ischemia-reperfusion injury at liver transplantation oxidative stress, hepatic endoplasmic reticulum (ER) stress and cholesterol metabolism are interrelated key processes to preserve graft regeneration and function. A blood sample is obtained in each subject to measure MELD score at the first visit and at liver transplantation. Further blood samples are collected at days seven and 30 post transplantation. Blood samples are also obtained from healthy subjects. Liver biopsy samples are obtained from liver transplant donors. Oxidative stress and fatty acids lipidomics are measured to evaluate the actual plasma concentration in liver cirrhosis patients to be compared with healthy controls. Oxidative stress and fatty acids are also analyzed as a function of disease status, and for its influence on transplant outcomes. Lipid metabolism gene and endoplasmic stress reticulum gene expression are evaluated in liver biopsy specimen to study the influence on graft function.

Conditions
Liver Cirrhosis
Keywords
liver cirrhosis, oxidative stress, liver transplant
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01389115
Study groupRoleWhat they receive
Liver CirrhosisPatient with liver cirrhosis undergoing liver transplant
Liver donorsSubjects eligible for organ explant
Healthy controlsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post operative graft function after liver transplantation

    • Multiple lipid metabolism biomarkers (fatty acids, cholesterol and oxysterols) are evaluated in the plasma of liver cirrhosis patients before liver transplantation. A logistic regression model is used to evaluate which of these biomarkers is an independent predictor of graft function

    Measured: Change in graft function after 7 and 30 days after liver transplantation

Secondary outcomes (1)

  1. Early gene expression in the liver graft

    Assessment of lipid metabolism-, oxidative stress-, and ER stress-gene expression in graft tissue liver tissue specimens of patients undergoing organ transplantation and their impact on graft function. Lipid metabolism and ER gene expression (genes: LDL-R, HMGCR, CD81, SREBP2, NPC1L1, XBP-1, XBP2, ATF6, GRP78, GRP94, LXR, INSIG1, INSIG2) in liver graft specimens at transplantation before and after ischemia-reperfusion injury; downregulated and upregulated genes are related to early graft function.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2011 (estimated)
  2. Study startJul 2001
  3. Primary completionMay 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01389115
Sponsor's protocol ID
Iul_LC
Status last verified
Dec 2015
First submitted
6 May 2011
Last updated
11 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Poli G. Pathogenesis of liver fibrosis: role of oxidative stress. Mol Aspects Med. 2000 Jun;21(3):49-98. doi: 10.1016/s0098-2997(00)00004-2.

    PubMed 10978499

  • Loguercio C, Federico A. Oxidative stress in viral and alcoholic hepatitis. Free Radic Biol Med. 2003 Jan 1;34(1):1-10. doi: 10.1016/s0891-5849(02)01167-x.

    PubMed 12498974

  • Iuliano L, Monticolo R, Straface G, Zullo S, Galli F, Boaz M, Quattrucci S. Association of cholesterol oxidation and abnormalities in fatty acid metabolism in cystic fibrosis. Am J Clin Nutr. 2009 Sep;90(3):477-84. doi: 10.3945/ajcn.2009.27757. Epub 2009 Jul 8.

    PubMed 19587087

  • Al Sibae MR, Cappell MS. Accuracy of MELD scores in predicting mortality in decompensated cirrhosis from variceal bleeding, hepatorenal syndrome, alcoholic hepatitis, or acute liver failure as well as mortality after non-transplant surgery or TIPS. Dig Dis Sci. 2011 Apr;56(4):977-87. doi: 10.1007/s10620-010-1390-3. Epub 2010 Sep 16.

    PubMed 20844956

  • Corradini SG, Micheletta F, Natoli S, Iappelli M, Di Angelantonio E, De Marco R, Elisei W, Siciliano M, Rossi M, Berloco P, Attili AF, Diczfalusy U, Iuliano L. High preoperative recipient plasma 7beta-hydroxycholesterol is associated with initial poor graft function after liver transplantation. Liver Transpl. 2005 Dec;11(12):1494-504. doi: 10.1002/lt.20524.

    PubMed 16258953

  • Iuliano L, Micheletta F, Natoli S, Ginanni Corradini S, Iappelli M, Elisei W, Giovannelli L, Violi F, Diczfalusy U. Measurement of oxysterols and alpha-tocopherol in plasma and tissue samples as indices of oxidant stress status. Anal Biochem. 2003 Jan 15;312(2):217-23. doi: 10.1016/s0003-2697(02)00467-0.

    PubMed 12531208

  • Corradini SG, Elisei W, De Marco R, Siciliano M, Iappelli M, Pugliese F, Ruberto F, Nudo F, Pretagostini R, Bussotti A, Mennini G, Eramo A, Liguori F, Merli M, Attili AF, Muda AO, Natalizi S, Berloco P, Rossi M. Preharvest donor hyperoxia predicts good early graft function and longer graft survival after liver transplantation. Liver Transpl. 2005 Feb;11(2):140-51. doi: 10.1002/lt.20339.

    PubMed 15666381

  • Ginanni Corradini S, Zerbinati C, Maldarelli F, Palmaccio G, Parlati L, Bottaccioli AG, Molinaro A, Poli E, Boaz M, Serviddio G, Mennini G, Corsi A, Bianco P, Rossi M, Iuliano L. Plasma fatty acid lipidome is associated with cirrhosis prognosis and graft damage in liver transplantation. Am J Clin Nutr. 2014 Aug;100(2):600-8. doi: 10.3945/ajcn.113.074427. Epub 2014 Jun 25.

    PubMed 24965302

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhosis, run by University of Roma La Sapienza at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. 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 Stefano Corradini, M.D., Ph.D. (+390649972086, stefano.corradini@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post operative graft function after liver transplantation (time frame: Change in graft function after 7 and 30 days after liver transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01389115, which also lists 8 linked publications.

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 11 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in