Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05250401 |
| Other study ID # |
R.21.05.1317 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 18, 2021 |
| Est. completion date |
January 18, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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
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).
