| NCT ID | NCT07181018 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poznan University of Medical Sciences |
| Condition | Twins |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2025-09-01 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Over a 5-year follow-up period, we aim to conduct a study among twins aged 15-44 years from the Polish population with the following objectives: 1. To determine the incidence and risk factors for the development of de novo metabolic dysfunction-associated steatotic liver disease (MASLD), liver fibrosis, or cirrhosis. We also intend to evaluate the progression of hepatic steatosis from early to advanced stages or toward fibrosis/cirrhosis. 2. To determine the prevalence and identify predictive factors for the onset and progression of features, diseases, or complications of metabolic syndrome (MS) other than liver disease, particularly within the spectrum of metabolic, nutritional, cardiovascular, endocrine, oncological, psychological, and other disorders typically associated with MS. 3. To assess the association between previous COVID-19 infection or long-COVID features and the occurrence of MASLD, liver fibrosis, or cirrhosis due to MASLD, as well as other features, diseases, or complications of MS. 4. To evaluate the prevalence of malignancies in a young twin population (aged 15-44 years) with MS or with risk factors for MS. 5. To investigate the contribution of genetic and environmental factors and gut microbiota composition to the development and progression of structural liver changes (steatosis, fibrosis, cirrhosis) in MASLD, as well as other features and complications of MS in twins discordant for the MS phenotype. 6. To assess the role of genetic and environmental components in the occurrence and severity of MS phenotype discordance in monozygotic twins.
Eligibility Criteria
Inclusion Criteria 1\. Age between 15 and 44 years. 2. Provision of informed consent to participate in the study. 3. Twin with a living co-twin. 4. Positive family history in first- and second-degree relatives of metabolic syndrome (MS), associated diseases, or the most common complications of the syndrome. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Exclusion Criteria Permanent exclusion criteria: 1. Co-twin does not consent to participate in the study. 2. Inability to obtain medical history of biological family members. 3. Presence of advanced liver fibrosis, cirrhosis, or liver cancer. 4. Known liver genetic disorders, autoimmune hepatitis, celiac disease, hemochromatosis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), cystic fibrosis, or Wilson's disease. 5. Current or chronic alcohol consumption \>20 g of ethanol/day in women and \>30 g/day in men. 6. Short bowel syndrome. 7. Cyanotic congenital heart defect. 8. Myasthenia. 9. Central nervous system degenerative diseases such as Alzheimer's disease, Parkinson's disease, or Huntington's disease. 10. Storage diseases involving the liver. 11. Active malignant neoplasm undergoing treatment (excluding non-melanoma skin cancers and melanoma treated non-pharmacologically). 12. Chronic kidney disease requiring renal replacement therapy. 13. Status post organ or tissue transplantation requiring immunosuppression. 14. Pituitary, hypothalamic, or adrenal hyperfunction/hypofunction requiring hormone supplementation. 15. Addiction to psychoactive substances or drugs. 16. Other severe and incurable diseases that, in the investigator's opinion, constitute a permanent contraindication for participation in the study. 17. Lack of cooperation by the volunteer during the visit to the Research Center. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Temporary exclusion criteria (after resolution, the volunteer may be enrolled): 1. Acute infection, low-grade fever or fever, or use of antibiotics at the time of recruitment or prior to the visit at the Research Center - inclusion possible after 6 weeks. 2. Any vaccination within the past 6 weeks. 3. Pregnancy and up to 6 months postpartum. 4. 3 months after the natural cessation of breastfeeding. 5. 3 months after surgery (does not apply to minor surgical procedures). 6. Untreated hyperthyroidism or hypothyroidism - inclusion possible 3 months after achieving euthyroidism. 7. Significant weight loss or gain in the past 3 months (\>10% of initial body weight) - inclusion possible 3 months after weight stabilization. 8. 6 months after discontinuation of temporary parenteral or enteral nutrition via feeding tube. 9. 12 months after bariatric surgery. 10. Systemic treatment with steroids, chemotherapy, immunosuppressive drugs, or biological therapy known to be hepatotoxic or potentially inducing abnormalities found in MS - inclusion possible at least 3 months after completing therapy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07181018 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 44 Years, studying Twins. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07181018 currently recruiting?
Yes, NCT07181018 is actively recruiting participants. Contact the research team at piotreder@ump.edu.pl for enrollment information.
Where is the NCT07181018 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT07181018 clinical trial?
NCT07181018 is sponsored by Poznan University of Medical Sciences. The trial plans to enroll 1,500 participants.