Fatty Liver DiseaseNCT06071923
Effect of Thyroid Disorders in Liver Diseases
An observational study of Fatty Liver Disease, run by Assiut University.
Trial summary
Aims of the Research 1. To detect correlation between hyperthyroidism and non alcoholic fatty liver disease (NAFLD). 2. To detect hepatic risk in subclinical and clinical hypothyroidism . 3. To detect early liver disorders in thyroid disorders using fibroscan . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fatty Liver Disease
- What is being tested?
- Fibroscan
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to Feb 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thyroid disorders and age above 18 years
Who may be able to join
- The study will include thyroid patients over one year duration ( age above 18 years old
Who cannot join
- History of liver failure or patient known to have congenital liver disease.
- Medications associated with weight gain .
- Patients who have diabetes mellitus.
- patients who already have liver disease eg; chronic viral hepatitis, liver cirrhosis.
- Patients on antistatin.
Trial locations and contacts
No sites are listed yet.
Hanan Mahmoud, Prof dr contact
About this study
Official title: Effect of Thyroid Disorders in Metabolic Fatty Liver Changes
Aims of the Research
- To detect correlation between hyperthyroidism and non alcoholic fatty liver disease (NAFLD).
- To detect hepatic risk in subclinical and clinical hypothyroidism .
- To detect early liver disorders in thyroid disorders using fibroscan .
Read the detailed description
Non alcoholic fatty liver disease (NAFLD) has been a health problem of growing significance all over the world; its prevalence is increasing in both developed and developing countries ,the overall prevalence of NAFLD worldwide was estimated to be 32.4%.prevalence increased significantly over time.
considering the increasing incidence of NALAD/NASH, especially in developed and developing countries, it is anticipated that cirrhosis due to these conditions may exceed other causes of cirrhosis in a near future..
Thyroid gland is involved in energy homeostasis, lipid and carbohydrate metabolism, regulation of body weight and adipogenesis.
In a clinical setting, subclinical hypothyroidism has been associated with metabolic syndrome, cardiovascular mortality and disturbance of lipid metabolism.
The prevalence of hypothyroidism was reported to 16.8% among patients with NAFLD/NASH.
In recent years, growing body of evidence has led to speculation on the association between NAFLD/NASH and thyroid dysfunction.
Therefore, understanding the pathophysiology, risk factors and new treatment options of NAFLD/NASH should be among the priorities in the field of hepatology
- Conditions
- Fatty Liver Disease
- Being tested
- Fibroscan
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDevice
Scan the liver for metabolic fatty changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect correlation between hyperthyroid diseases and NASH .
Test the patients of thyroid disorders for metabolic fatty liver changes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071923
- Sponsor's protocol ID
- 04-2023-200396
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thyroid Disorders in Metabolic Fatty Liver Changes
- ClinicalTrials.gov ID
- NCT06071923
- Acronym / sponsor ID
- 04-2023-200396
- Conditions
- Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 10 Oct 2023 (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.
Aims of the Research
- To detect correlation between hyperthyroidism and non alcoholic fatty liver disease (NAFLD).
- To detect hepatic risk in subclinical and clinical hypothyroidism .
- To detect early liver disorders in thyroid disorders using fibroscan .
Detailed description
Non alcoholic fatty liver disease (NAFLD) has been a health problem of growing significance all over the world; its prevalence is increasing in both developed and developing countries ,the overall prevalence of NAFLD worldwide was estimated to be 32.4%.prevalence increased significantly over time.
considering the increasing incidence of NALAD/NASH, especially in developed and developing countries, it is anticipated that cirrhosis due to these conditions may exceed other causes of cirrhosis in a near future..
Thyroid gland is involved in energy homeostasis, lipid and carbohydrate metabolism, regulation of body weight and adipogenesis.
In a clinical setting, subclinical hypothyroidism has been associated with metabolic syndrome, cardiovascular mortality and disturbance of lipid metabolism.
The prevalence of hypothyroidism was reported to 16.8% among patients with NAFLD/NASH.
In recent years, growing body of evidence has led to speculation on the association between NAFLD/NASH and thyroid dysfunction.
Therefore, understanding the pathophysiology, risk factors and new treatment options of NAFLD/NASH should be among the priorities in the field of hepatology
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid disorders and age above 18 years
Key inclusion criteria (1 listed)
- The study will include thyroid patients over one year duration ( age above 18 years old
Key exclusion criteria (5 listed)
- History of liver failure or patient known to have congenital liver disease.
- Medications associated with weight gain .
- Patients who have diabetes mellitus.
- patients who already have liver disease eg; chronic viral hepatitis, liver cirrhosis.
- Patients on antistatin.
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 |
|---|---|---|
| FibroscanScan the liver for metabolic fatty changes | Device | – |
Primary outcome
Detect correlation between hyperthyroid diseases and NASH .
Time frame: Baseline
Test the patients of thyroid disorders for metabolic fatty liver changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Related trials for Fatty Liver Disease
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
RecruitingPhase 3
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
Active, not recruitingObservational study
Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Hyperuricemia and MAFLD
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.
Hanan Mahmoud, Prof dr contact
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver Disease, run by Assiut University.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tasneem Mohammed Ali, Master (01098704665, Tonamohammed96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect correlation between hyperthyroid diseases and NASH . (time frame: Baseline). 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 10 Oct 2023.