NCT02926261

Brief Summary

Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis. Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

October 5, 2016

Last Update Submit

February 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Characterization of nutritional status by three methods of nutritional assessment * Bioelectrical impedance vector analysis * CT scan * Handgrip strength

    Evaluation at time of recruitment

Interventions

Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cohort of patients with cirrhosis

You may qualify if:

  • Diagnosis of cirrhosis
  • No restriction of etiology
  • years
  • Child-Pugh stage A/B/C
  • Signed informed consent

You may not qualify if:

  • Pregnancy
  • Extremity amputation
  • Malignancy different from hepatocellular carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples collected at time of evaluation and stored at -80°.

MeSH Terms

Conditions

Liver CirrhosisCachexiaMalnutrition

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinnessNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Aldo Torre, MD, MSc

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Torre, MD, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 6, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

February 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations