Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06536933
Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Sohag University at 1 site in Egypt.
Trial summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the latest term for steatotic liver disease associated with metabolic syndrome. MASLD is a common cause of chronic liver disease and is the leading cause of liver-related morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Abdominal Ultrasound
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 31 Dec 2024
- 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 60 years
- All sexes
- Adult
Study population: 100 Employees in Sohag University will be included in the study.
Who may be able to join
- 100 Employees in Sohag University will be included in the study.
Who cannot join
- Employees with drug induced liver disease. Employees with chronic liver disease. Employees with decompensated liver cirrhosis. Employees with excessive alcohol consumption.
Trial locations and contacts
1 site in 1 country.
Ali T A, professor contact
About this study
- Metabolic dysfunction-associated steatotic liver disease (MASLD) is the latest term for steatotic liver disease associated with metabolic syndrome. MASLD is a common cause of chronic liver disease and is the leading cause of liver-related morbidity and mortality.
- The high prevalence of this disease has been fueled by the rapid rise in levels of sedentary behavior, low levels of physical activity, excess calorie intake relative to expenditure in nutritionally imbalanced and unhealthy diets. In parallel, the prevalence of poor metabolic health in adults from many countries is high, even in normal weight individuals.
- MASLD has been estimated to affect 30% of the adult population worldwide, with its prevalence increasing from 22% to 37% from 1991 to 2019 . The increasing prevalence of MASLD parallels the increasing prevalence of obesity and obesity-related diseases.
- Being tested
- Abdominal Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal UltrasoundDiagnostic test
Diagnostic non invasive Abdomibal Ultrasound will be done to quantify hepatic steatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
waist circumference
by using a flexible non-stretchable measuring tape by identifying measurement point midway between the lower margin of last palpable rib and the top of iliac crest.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Eldin Hamdy Hamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536933
- Sponsor's protocol ID
- Soh-Med-24-07-19MS
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chan WK, Chuah KH, Rajaram RB, Lim LL, Ratnasingam J, Vethakkan SR. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review. J Obes Metab Syndr. 2023 Sep 30;32(3):197-213. doi: 10.7570/jomes23052. Epub 2023 Sep 13.
PubMed 37700494Inoue Y, Qin B, Poti J, Sokol R, Gordon-Larsen P. Epidemiology of Obesity in Adults: Latest Trends. Curr Obes Rep. 2018 Dec;7(4):276-288. doi: 10.1007/s13679-018-0317-8.
PubMed 30155850Stefan N, Schick F, Haring HU. Causes, Characteristics, and Consequences of Metabolically Unhealthy Normal Weight in Humans. Cell Metab. 2017 Aug 1;26(2):292-300. doi: 10.1016/j.cmet.2017.07.008.
PubMed 28768170Chan WK, Treeprasertsuk S, Imajo K, Nakajima A, Seki Y, Kasama K, Kakizaki S, Fan JG, Song MJ, Yoon SK, Dan YY, Lesmana L, Ho KY, Goh KL, Wong VW. Clinical features and treatment of nonalcoholic fatty liver disease across the Asia Pacific region-the GO ASIA initiative. Aliment Pharmacol Ther. 2018 Mar;47(6):816-825. doi: 10.1111/apt.14506. Epub 2018 Jan 14.
PubMed 29333610
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees
- ClinicalTrials.gov ID
- NCT06536933
- Acronym / sponsor ID
- Soh-Med-24-07-19MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Aug 2024 (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.
- Metabolic dysfunction-associated steatotic liver disease (MASLD) is the latest term for steatotic liver disease associated with metabolic syndrome. MASLD is a common cause of chronic liver disease and is the leading cause of liver-related morbidity and mortality.
- The high prevalence of this disease has been fueled by the rapid rise in levels of sedentary behavior, low levels of physical activity, excess calorie intake relative to expenditure in nutritionally imbalanced and unhealthy diets. In parallel, the prevalence of poor metabolic health in adults from many countries is high, even in normal weight individuals.
- MASLD has been estimated to affect 30% of the adult population worldwide, with its prevalence increasing from 22% to 37% from 1991 to 2019 . The increasing prevalence of MASLD parallels the increasing prevalence of obesity and obesity-related diseases.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- 100 Employees in Sohag University will be included in the study.
Key inclusion criteria (1 listed)
- 100 Employees in Sohag University will be included in the study.
Key exclusion criteria (1 listed)
- Employees with drug induced liver disease. Employees with chronic liver disease. Employees with decompensated liver cirrhosis. Employees with excessive alcohol consumption.
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 |
|---|---|---|
| Abdominal UltrasoundDiagnostic non invasive Abdomibal Ultrasound will be done to quantify hepatic steatosis | Diagnostic test | – |
Primary outcome
waist circumference
Time frame: 4 months
by using a flexible non-stretchable measuring tape by identifying measurement point midway between the lower margin of last palpable rib and the top of iliac crest.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 37700494Chan WK, Chuah KH, Rajaram RB, Lim LL, Ratnasingam J, Vethakkan SR. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review. J Obes Metab Syndr. 2023 Sep 30;32(3):197-213. doi: 10.7570/jomes23052. Epub 2023 Sep 13.
- Background: PubMed 30155850Inoue Y, Qin B, Poti J, Sokol R, Gordon-Larsen P. Epidemiology of Obesity in Adults: Latest Trends. Curr Obes Rep. 2018 Dec;7(4):276-288. doi: 10.1007/s13679-018-0317-8.
- Background: PubMed 28768170Stefan N, Schick F, Haring HU. Causes, Characteristics, and Consequences of Metabolically Unhealthy Normal Weight in Humans. Cell Metab. 2017 Aug 1;26(2):292-300. doi: 10.1016/j.cmet.2017.07.008.
- Background: PubMed 29333610Chan WK, Treeprasertsuk S, Imajo K, Nakajima A, Seki Y, Kasama K, Kakizaki S, Fan JG, Song MJ, Yoon SK, Dan YY, Lesmana L, Ho KY, Goh KL, Wong VW. Clinical features and treatment of nonalcoholic fatty liver disease across the Asia Pacific region-the GO ASIA initiative. Aliment Pharmacol Ther. 2018 Mar;47(6):816-825. doi: 10.1111/apt.14506. Epub 2018 Jan 14.
- Individual participant dataSharing planned: Undecided
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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.
Ali T A, professor contact
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 Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Sohag 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 1 inclusion and 1 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 5 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossam Eldin H H, resident (01020678907, hossamhamdy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waist circumference (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536933, which also lists 4 linked publications.
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 5 Aug 2024.