NCT07095010Completed
Lifestyle Habits and Metabolic Dysfunction-Associated Steatotic Liver Disease in Youth
Evaluation of the Role of Lifestyle Habits in the Presence of Metabolic Dysfunction-associated Steatotic Liver Disease in a Sample of Greek Children and Adolescents
Source: ClinicalTrials.gov · Last updated 1 Aug 2025
Brief summary (registry, in English)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease in children and adolescents. Lifestyle factors are modifiable risk factors that may play a key role in both the prevention and management of the disease. However, existing data on the association between lifestyle and MASLD in pediatric populations are limited and often focus on isolated aspects such as diet or physical activity, with little attention given to other parameters like sleep habits. The aim of the present study is to comprehensively investigate the association between lifestyle factors, including dietary habits, physical activity, sedentary activities, and sleep habits, and the presence of MASLD in a sample of 224 children and adolescents with overweight or obesity. The study will include newly diagnosed MASLD patients compared to matched controls without the disease. A wide range of assessments will be conducted, including anthropometric measurements, body composition analysis, liver elastography, biochemical testing, and standardized lifestyle questionnaires. This study seeks to fill important research gaps and explore potential associations between lifestyle habits and pathophysiological markers involved in the onset and progression of MASLD.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 224 (actual)
- First submitted
- 6 Jun 2025
- Start date
- 10 Jan 2022
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Harokopio University
- Diseases
- Obesity
- NCT number
- NCT07095010
What you commit to
- Study type: Observational
- Participants enrolled: 224
- From 10 Jan 2022 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes mellitus
Other
- Alcohol consumption
- Malnutrition or parenteral nutrition
- Thyroid function
- Recent changes in diet and physical activity habits aimed at weight loss and/or improvement of health parameters in newly diagnosed children and adolescents
Who the study is looking for
- Age: Children and adolescents aged 10 to 18 years, of Caucasian ethnicity, regardless of sex or nationality.
- Overweight or Obesity: Children/adolescents with overweight or obesity according to World Health Organization (WHO) criteria for ages 5-19.
- Newly Diagnosed Metabolic Dysfunction-Associated Steatotic Liver Disease: Diagnosis will be established in participants who meet all of the following criteria:
- Elevated ALT levels (\>45 IU/L), according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, and/or evidence of hepatic steatosis on liver ultrasound.
- Exclusion of other causes of liver damage or steatosis, including negative for HBsAg, anti-HIV, and anti-HCV antibodies, no autoimmune hepatitis, no viral infections, systemic or metabolic diseases, no celiac disease, chronic kidney disease, normal ceruloplasmin levels (to rule out Wilson's disease), no hepatotoxic medications.
Age in the registry: 10 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harokopio University Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.