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.
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.
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
- Full written informed consent will be obtained from all patients.
- Patient demographics.
- The diagnosis of cirrhosis was based on case history, clinical examination, biochemical, endoscopic and ultrasound findings.
- 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)
- The degree of encephalopathy was defined on the basis of previously reported criteria ranked between Grade 1 and Grade 4.
- 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 group | Role | What they receive |
|---|---|---|
| patients with liver cirrhosis | Not described Receives: Diagnostic Test: liver functions and thyroid functions | |
| control group | Not 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.
thyroid stimulating hormone
TSH in μIU/ml
Measured: 1 year
Triiodothyronine
T3 in pg/ml
Measured: 1 year
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.
- First posted22 Feb 2022
- Study start18 May 2021
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gameel, Mansoura University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Function in Liver Cirrhosis: Is it Affected?
- ClinicalTrials.gov ID
- NCT05250401
- Acronym / sponsor ID
- R.21.05.1317
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- 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.
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
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
- Full written informed consent will be obtained from all patients.
- Patient demographics.
- The diagnosis of cirrhosis was based on case history, clinical examination, biochemical, endoscopic and ultrasound findings.
- 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)
- The degree of encephalopathy was defined on the basis of previously reported criteria ranked between Grade 1 and Grade 4.
- 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with liver cirrhosis | – | Diagnostic Test: liver functions and thyroid functions |
| control group | – | Diagnostic Test: liver functions and thyroid functions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver functions and thyroid functionslaboratory tests | Diagnostic test | control group, patients with liver cirrhosis |
Primary outcome
thyroid stimulating hormone
Time frame: 1 year
TSH in μIU/ml
Triiodothyronine
Time frame: 1 year
T3 in pg/ml
thyroxine
Time frame: 1 year
T4 in ng/dl
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.