NCT06536933

Brief 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.
  • 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 31, 2024

Last Update Submit

July 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Interventions

Abdominal UltrasoundDIAGNOSTIC_TEST

Diagnostic non invasive Abdomibal Ultrasound will be done to quantify hepatic steatosis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

100 Employees in Sohag University will be included in the study.

You may qualify if:

  • Employees in Sohag University will be included in the study.

You may not qualify if:

  • Employees with drug induced liver disease. Employees with chronic liver disease. Employees with decompensated liver cirrhosis. Employees with excessive alcohol consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 37700494BACKGROUND
  • Inoue 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.

    PMID: 30155850BACKGROUND
  • Stefan 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.

    PMID: 28768170BACKGROUND
  • Chan 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.

    PMID: 29333610BACKGROUND

Central Study Contacts

Hossam Eldin H H, resident

CONTACT

Ali T A, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-Internal Medicine department-sohag hospital university

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 5, 2024

Record last verified: 2024-07

Locations