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Cirrhosis, Effects of TRAnsplantation and Diabetes (CETRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor:
Information provided by (Responsible Party):
Emanuela Orsi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT02038517
First received: January 10, 2014
Last updated: February 29, 2016
Last verified: February 2016
  Purpose
This observational study is aimed at assessing insulin secretion and sensitivity by the use of a mathematical modeling from oral glucose tolerance test in subjects with liver cirrhosis undergoing orthotopic liver transplantation (OLT), before and at various time points after OLT.

Condition
Liver Cirrhosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Insulin Secretion and Sensitivity in Subjects With Liver Cirrhosis Undergoing Orthotopic Liver Transplantation (OLT): Pre- and Post-OLT Analysis

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • Relationship of insulin secretion and sensitivity with the development of abnormalities of glucose metabolism after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Relation between baseline values and changes with transplantation of measures of insulin secretion and sensitivity, as derived from of the analysis of OGTT by the use of a mathematical model (i.e. proportional and derivative control for insulin secretion and oral glucose insulin sensitivity - OGIS - for insulin sensitivity ) and the development of abnormalities of glucose metabolism after OLT.


Secondary Outcome Measures:
  • Relationship of insulin secretion and sensitivity with morbidity and mortality after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Relation between baseline values and changes with transplantation of measures of insulin secretion and sensitivity, as derived from of the analysis of OGTT by the use of a mathematical model (i.e. proportional and derivative control for insulin secretion and oral glucose insulin sensitivity - OGIS - for insulin sensitivity ) and morbidity and mortality after OLT.

  • Relationship of insulin secretion and sensitivity with the development of the metabolic syndrome after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Relation between baseline values and changes with transplantation of measures of insulin secretion and sensitivity, as derived from of the analysis of OGTT by the use of a mathematical model (i.e. proportional and derivative control for insulin secretion and oral glucose insulin sensitivity - OGIS - for insulin sensitivity ) and the development of the metabolic syndrome and its components (impaired glucose metabolism, central obesity, dyslipidemia and hypertension) after OLT.


Other Outcome Measures:
  • Prevalence and incidence of impaired glucose metabolism (IFG, IGT and diabetes) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Prevalence of unknown diabetes mellitus or IGT (normal levels of fasting glucose and HbA1c) pre-OLT and incidence of new-onset diabetes after transplantation (NODAT) or IFG/IGT

  • Prevalence and incidence of the metabolic syndrome and its components (central) obesity , dyslipidemia and hypertension [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Prevalence of the metabolic syndrome and its components (National Cholesterol Education Program - Adult Treatment Panel criteria, 2004 revision) pre-OLT and incidence of new-onset metabolic syndrome after transplantation

  • Morbidity and mortality after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Morbidity and mortality from OLT-related and unrelated causes, including rejection, infection, and cardiovascular disease


Biospecimen Retention:   Samples With DNA
Serum, plasma, urines and DNA

Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Secondary care outpatients clinic
Criteria

Inclusion Criteria:

Subjects with end-stage liver cirrhosis in waiting list for orthotopic liver transplantation at the Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy

Exclusion Criteria:

  • Known diabetes
  • Cystic fibrosis
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038517

Contacts
Contact: Emanuela Orsi, MD +390255034590 e.orsi@policlinico.mi.it

Locations
Italy
Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico Recruiting
Milan, MI, Italy, 20122
Contact: Emanuela Orsi, MD    +390255034590    e.orsi@policlinico.mi.it   
Sub-Investigator: Elena Lunati, MD         
Sub-Investigator: Valeria Grancini, MD         
Sub-Investigator: Eva Palmieri, MD         
Sub-Investigator: Dario Zimbalatti, MD         
Sub-Investigator: Veronica Resi, MD         
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Emanuela Orsi, MD Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy
  More Information

Responsible Party: Emanuela Orsi, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT02038517     History of Changes
Other Study ID Numbers: EDOMP-1301 
Study First Received: January 10, 2014
Last Updated: February 29, 2016
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Insulin secretion
Insulin sensitivity
Orthotopic liver transplantation
Type 2 diabetes
Metabolic syndrome
Cardiovascular disease

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016