Changes in Body Composition and Nutritional Status in Patients Undergoing Liver Transplantation
1 other identifier
observational
60
1 country
1
Brief Summary
Liver transplant is the goal treatment for every patient with end-stage chronic liver disease. Quality of life improves after transplant because the main complications of end-stage liver disease disappear, but due to immunosuppression other alterations appear such as metabolic alterations, weight gain, among others. Body composition and nutritional status can be affected do to post-transplant pharmacologic therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedStudy Start
First participant enrolled
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 2, 2020
February 1, 2020
1.9 years
December 18, 2013
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body composition
Body composition will be assessed through bioelectrical impedance vector analysis graph.
Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Secondary Outcomes (1)
Liver function tests
Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Study Arms (1)
Nutritional assessment
Nutritional assessment will be performed by bioelectrical impedance vector analysis
Eligibility Criteria
Patients will be selected from the transplant enrollment list at the Department of Gastroenterology in a tertiary care center in Mexico
You may qualify if:
- Liver cirrhosis (any etiology)
- Enrolled in waiting list for tliver transplant
You may not qualify if:
- Hepatocellular carcinoma
- Chronic renal failure
- Congestive cardiac failure
- Extremity amputation
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aldo Torre, MD MSci
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- PRINCIPAL INVESTIGATOR
Astrid Ruiz-Margáin, M.Sci
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 30, 2013
Study Start
January 3, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2022
Last Updated
March 2, 2020
Record last verified: 2020-02