NCT05250401

Brief Summary

In patient with liver cirrhosis ,thyroid functions are largely affected in our study we studied the changes in thyroid functions in patients with liver cirrhosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 18, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

January 27, 2022

Last Update Submit

February 21, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • thyroid stimulating hormone

    TSH in μIU/ml

    1 year

  • Triiodothyronine

    T3 in pg/ml

    1 year

  • thyroxine

    T4 in ng/dl

    1 year

Study Arms (2)

patients with liver cirrhosis

Diagnostic Test: liver functions and thyroid functions

control group

Diagnostic Test: liver functions and thyroid functions

Interventions

laboratory tests

control grouppatients with liver cirrhosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Sex: both * Age:18-80 years. * Known and established cases of cirrhosis liver by clinical, radiological (ultrasound abdomen), and biochemical study. * Patients who were willing to part of study after consent. * Control - Apparently healthy age- and sex-matched individuals between 18 and 80 years * Age: below 18 or above 80 years old. * Known cases of thyroid disorder without liver cirrhosis. * Patient with history of organ failure, cancer, radio or chemotherapy and individual with active infection such as bone and muscle disease, cardiac, pancreatic (diabetes), chronic kidney disease, nephrotic syndrome. * Patient using drugs that interfere with thyroid metabolism such as levothyroxine, propylthiouracil, carbimazole, iodine, amiodarone, and beta-blockers.

You may qualify if:

  • Sex: both
  • Age:18-80 years.
  • Known and established cases of cirrhosis liver by clinical, radiological (ultrasound abdomen), and biochemical study.
  • Patients who were willing to part of study after consent.
  • Control - Apparently healthy age- and sex-matched individuals between 18 and 80 years.

You may not qualify if:

  • Age: below 18 or above 80 years old.
  • Known cases of thyroid disorder without liver cirrhosis.
  • Patient with history of organ failure, cancer, radio or chemotherapy and individual with active infection such as bone and muscle disease, cardiac, pancreatic (diabetes), chronic kidney disease, nephrotic syndrome.
  • Patient using drugs that interfere with thyroid metabolism such as levothyroxine, propylthiouracil, carbimazole, iodine, amiodarone, and beta-blockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MansouraU

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 22, 2022

Study Start

May 18, 2021

Primary Completion

January 18, 2022

Study Completion

January 18, 2022

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations