Liver CirrhosisNCT02023190
Changes in Body Composition and Nutritional Status in Patients Undergoing Liver Transplantation
An observational study of Liver Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 3 Jan 2019to Dec 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be selected from the transplant enrollment list at the Department of Gastroenterology in a tertiary care center in Mexico
Who may be able to join
- Liver cirrhosis (any etiology)
- Enrolled in waiting list for tliver transplant
Who cannot join
- Hepatocellular carcinoma
- Chronic renal failure
- Congestive cardiac failure
- Extremity amputation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
Aldo Torre, MD MSci, 54870900 ext. 2711, detoal@yahoo.com
Astrid Ruiz-Margain, M.Sci, 54870900 ext. 2711, ruizm.astrid@gmail.com
About this study
Official title: Changes in Body Composition and Nutritional Status Assessed by Bioelectrical Impedance Vector Analysis in Cirrhotic Patients Undergoing Liver Transplantation
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.
Read the detailed description
Body composition and nutritional status can be affected due to post-transplant pharmacologic therapy.
This is a prospective cohort study, patients from liver transplant waiting list will be assessed, pre and post-transplant measures of body composition and nutritional status will be obtained.
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, liver transplant, nutritional status, bioelectrical impedance vector analysis
- 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 group | Role | What they receive |
|---|---|---|
| Nutritional assessment | Nutritional assessment will be performed by bioelectrical impedance vector analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Body composition will be assessed through bioelectrical impedance vector analysis graph.
Measured: Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Secondary outcomes (1)
Liver function tests
Measured: Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study start3 Jan 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre, MD MSci, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranAstrid Ruiz-Margáin, M.Sci, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023190
- Sponsor's protocol ID
- LT01
- Status last verified
- Feb 2020
- First submitted
- 18 Dec 2013
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Body Composition and Nutritional Status Assessed by Bioelectrical Impedance Vector Analysis in Cirrhotic Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT02023190
- Acronym / sponsor ID
- LT01
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, liver transplant, nutritional status, bioelectrical impedance vector analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Dec 2013 (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.
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.
Detailed description
Body composition and nutritional status can be affected due to post-transplant pharmacologic therapy.
This is a prospective cohort study, patients from liver transplant waiting list will be assessed, pre and post-transplant measures of body composition and nutritional status will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional assessment | – | –Nutritional assessment will be performed by bioelectrical impedance vector analysis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be selected from the transplant enrollment list at the Department of Gastroenterology in a tertiary care center in Mexico
Key inclusion criteria (2 listed)
- Liver cirrhosis (any etiology)
- Enrolled in waiting list for tliver transplant
Key exclusion criteria (5 listed)
- Hepatocellular carcinoma
- Chronic renal failure
- Congestive cardiac failure
- Extremity amputation
- Pregnancy
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
Body composition
Time frame: Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Body composition will be assessed through bioelectrical impedance vector analysis graph.
1 secondary outcome
Liver function tests
Time frame: Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
Related trials for Liver Cirrhosis
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
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.
Aldo Torre, MD MSci study chair
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Astrid Ruiz-Margáin, M.Sci principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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 Liver Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 5 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 2 Mar 2020. 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 Mexico. 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 Aldo Torre, MD MSci (54870900 ext. 2711, detoal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant). It is what the study was designed to measure, not a finding.
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 2 Mar 2020.