NCT05813301

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most important chronic liver disease in the western world, affecting almost 30% of the general population. Moreover, the prevalence of NAFLD can be higher in type 2 diabetic patients and obese patients, affecting up to 90% of people with a body mass index higher than 40 kg/m2. NAFLD is also the most rapidly increasing cause of hepatic cirrhosis requiring hepatic transplantation in the future. The pathophysiology of NAFLD is complex and involves multiple hits, but the principal contributing factor to its development is hepatic lipid accumulation, which leads to hepatic insulin resistance

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Nov 2023

Typical duration for all trials

Status
not yet recruiting

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 Progress90%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

January 13, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

January 13, 2023

Last Update Submit

April 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • to estimate the percentage of NAFLD in patients of hypothyoidism

    through performing abdominal ultrasound to at least 100 patients of hypothyoidism

    in about one year

Eligibility Criteria

Age10 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hypothyroidism patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Tanase DM, Gosav EM, Neculae E, Costea CF, Ciocoiu M, Hurjui LL, Tarniceriu CC, Floria M. Hypothyroidism-Induced Nonalcoholic Fatty Liver Disease (HIN): Mechanisms and Emerging Therapeutic Options. Int J Mol Sci. 2020 Aug 18;21(16):5927. doi: 10.3390/ijms21165927.

    PMID: 32824723BACKGROUND
  • Kowalik MA, Columbano A, Perra A. Thyroid Hormones, Thyromimetics and Their Metabolites in the Treatment of Liver Disease. Front Endocrinol (Lausanne). 2018 Jul 10;9:382. doi: 10.3389/fendo.2018.00382. eCollection 2018.

    PMID: 30042736BACKGROUND
  • Chung GE, Kim D, Kim W, Yim JY, Park MJ, Kim YJ, Yoon JH, Lee HS. Non-alcoholic fatty liver disease across the spectrum of hypothyroidism. J Hepatol. 2012 Jul;57(1):150-6. doi: 10.1016/j.jhep.2012.02.027. Epub 2012 Mar 14.

    PMID: 22425701BACKGROUND
  • Perumpail BJ, Khan MA, Yoo ER, Cholankeril G, Kim D, Ahmed A. Clinical epidemiology and disease burden of nonalcoholic fatty liver disease. World J Gastroenterol. 2017 Dec 21;23(47):8263-8276. doi: 10.3748/wjg.v23.i47.8263.

    PMID: 29307986BACKGROUND
  • Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

    PMID: 26707365BACKGROUND
  • Zhu B, Chan SL, Li J, Li K, Wu H, Cui K, Chen H. Non-alcoholic Steatohepatitis Pathogenesis, Diagnosis, and Treatment. Front Cardiovasc Med. 2021 Sep 7;8:742382. doi: 10.3389/fcvm.2021.742382. eCollection 2021.

    PMID: 34557535BACKGROUND
  • Mandato C, D'Acunzo I, Vajro P. Thyroid dysfunction and its role as a risk factor for non-alcoholic fatty liver disease: What's new. Dig Liver Dis. 2018 Nov;50(11):1163-1165. doi: 10.1016/j.dld.2018.08.026. Epub 2018 Sep 1. No abstract available.

    PMID: 30262159BACKGROUND
  • He W, An X, Li L, Shao X, Li Q, Yao Q, Zhang JA. Relationship between Hypothyroidism and Non-Alcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. Front Endocrinol (Lausanne). 2017 Nov 29;8:335. doi: 10.3389/fendo.2017.00335. eCollection 2017.

    PMID: 29238323BACKGROUND
  • Sanyal D, Mukherjee P, Raychaudhuri M, Ghosh S, Mukherjee S, Chowdhury S. Profile of liver enzymes in non-alcoholic fatty liver disease in patients with impaired glucose tolerance and newly detected untreated type 2 diabetes. Indian J Endocrinol Metab. 2015 Sep-Oct;19(5):597-601. doi: 10.4103/2230-8210.163172.

    PMID: 26425466BACKGROUND
  • Liebe R, Esposito I, Bock HH, Vom Dahl S, Stindt J, Baumann U, Luedde T, Keitel V. Diagnosis and management of secondary causes of steatohepatitis. J Hepatol. 2021 Jun;74(6):1455-1471. doi: 10.1016/j.jhep.2021.01.045. Epub 2021 Feb 10.

    PMID: 33577920BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • wael ahmed abbas, prof

    Assiut University

    STUDY DIRECTOR
  • walaa anwer shehata, prof

    Assiut University

    STUDY DIRECTOR
  • mena sawerss fathy, residant

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mena sawerss fathy, residant

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturers

Study Record Dates

First Submitted

January 13, 2023

First Posted

April 14, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

April 14, 2023

Record last verified: 2023-04