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Liver CirrhosisNCT05250401

Thyroid Function in Liver Cirrhosis: Is it Affected?

An observational study of Liver Cirrhosis, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Liver Cirrhosis
What is being tested?
liver functions and thyroid functions
How many people
25 participants
Where
1 siteEgypt
Study dates
18 May 2021to 18 Jan 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 80 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • MansouraU

    Al Mansurah

Other trials in Egypt

About this study

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

Read the detailed description

In clinical terms, cirrhosis is described as are either "compensated" or "decompensated." Decompensation means cirrhosis complicated by one or more of the following features: jaundice, ascites, hepatic encephalopathy (HE), or bleeding varices. Ascites is the usual first sign.Hepatorenal syndrome, hyponatremia, and spontaneous bacterial peritonitis are also features of decompensation, but in these patients, ascites invariably occurs first. Compensated cirrhotic patients have none of these features.

The thyroid gland produces two-related hormones, thyroxine (T4) and triiodothyronine (T3). Acting through thyroid hormone receptors α and β, these hormones play a critical role in cell differentiation during development and help maintain thermogenic and metabolic homeostasis in the adult. T4 is secreted from the thyroid gland in about twenty-fold excess over T3. Both hormones are bound to plasma proteins, including thyroxine-binding globulin, transthyretin (formerly known as thyroxine binding prealbumin), and albumin.

The liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to T3 by Type 1 deiodinase. Type I deiodinase is the major enzyme in the liver and accounts for approximately 30%-40% of extrathyroidal production of T3, it can carry out both 5'-and 5-deiodination of T4 to T3. Moreover, the liver is involved in thyroid hormone conjugation and excretion, as well as the synthesis of thyroid binding globulin. T4 and T3 regulate the basal metabolic rate of all cells, including hepatocytes, and thereby modulate hepatic function. The liver metabolizes the THS and regulates their systemic endocrine effects. Thyroid diseases may perturb liver function; liver disease modulates thyroid hormone metabolism; and a variety of systemic diseases affect both the organs.

There are clinical and laboratory associations between thyroid and liver diseases. Patients with chronic liver disease may have thyroiditis, hyperthyroidism, or hypothyroidism. Patients with subacute thyroiditis or hyperthyroidism may have abnormalities in liver function tests, which return to normal as the thyroid condition improves.

Available studies showed most frequent change in plasma level of thyroid hormones is decreased total T3 and free T3 concentration which is reported to be associated with severity of hepatic dysfunction. But no study clearly mentioned FT4 and thyroid-stimulating hormone (TSH) levels with severity of liver cirrhosis. Serum T4 levels either remain normal or slightly low. However, serum TSH levels remain normal or slightly raised. These changes in thyroid hormone levels are so well established that some workers have advocated its use as a sensitive index of liver function.

Aim of work

  • Primary - To study thyroid hormone level (FT3, FT4, and TSH) in the liver cirrhosis patient.
  • Secondary - To find out the significance of thyroid hormone level and severity of cirrhosis of the liver.

Patients and Methods Study Design Case control study. Study groups This case-control study included apparently healthy controls (25 individiual) and liver cirrhosis patients (25 cases) from wards, outpatient department, and Intensive Care Unit in Specialized Medical Hospital with clinical, biochemical, and radiological evidence of cirrhosis of liver.

Sample size calculation was based on mean difference of between cases \& control groups retrieved from previous research.Sample size calculation was based on t test to compare between 2 means .Using G*power version 3.0.10 to calculate sample size , with the calculated sample size will be 50 (25 in each group) , 2 tailed test , α error =0.05 and power = 90.0% , effect size =0.95

Duration of study: 1 year Methods

  1. Full written informed consent will be obtained from all patients.
  2. Patient demographics.
  3. The diagnosis of cirrhosis was based on case history, clinical examination, biochemical, endoscopic and ultrasound findings.
  4. The functional severity of the liver injury was determined on the basis of the Child-Pugh grading system and model for end-stage liver disease (MELD)
  5. The degree of encephalopathy was defined on the basis of previously reported criteria ranked between Grade 1 and Grade 4.
  6. Thyroid function tests (TFT) (Salvatore et al., 2016) was done by electrochemiluminescence immunoassay. The normal range of thyroid profile as a following: FT3 is (2.1-4.4 pg/ml), FT4 is (0.8-2.7 ng/dl), and TSH is (0.35-5.5 μIU/ml).
Conditions
Liver Cirrhosis
Being tested
liver functions and thyroid functions
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • liver functions and thyroid functionsDiagnostic test

    laboratory tests

Study groups in NCT05250401
Study groupRoleWhat they receive
patients with liver cirrhosisNot described
Receives: Diagnostic Test: liver functions and thyroid functions
control groupNot described
Receives: Diagnostic Test: liver functions and thyroid functions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. thyroid stimulating hormone

    TSH in μIU/ml

    Measured: 1 year

  2. Triiodothyronine

    T3 in pg/ml

    Measured: 1 year

  3. thyroxine

    T4 in ng/dl

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start18 May 2021
  3. Primary completion18 Jan 2022
  4. Study completion18 Jan 2022

Resources

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
Case-control
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05250401
Sponsor's protocol ID
R.21.05.1317
Status last verified
Feb 2022
First submitted
27 Jan 2022
Last updated
22 Feb 2022
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhosis, run by Mansoura University at 1 site in Egypt.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Feb 2022. 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

thyroid stimulating hormone (time frame: 1 year). The study lists 3 primary outcomes in all. 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 22 Feb 2022.

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