Metabolic Syndrome Among Polish Twins

NCT07181018 | Recruiting DMC

• 1 other identifier: 2023/ABM/03/00048
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 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. 6.To assess the role of genetic and environmental components in the occurrence and severity of MS phenotype discordance in monozygotic twins.

Conditions

Twins; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• De novo occurrence of metabolic steatosis, hepatic fibrosis, or cirrhosis.

  De novo occurrence of metabolic steatosis, hepatic fibrosis, or cirrhosis based on assessment by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) and/or transient elastography.

  Baseline up to approximately 5 years

• Progression of hepatic steatosis or fibrosis to more advanced stages or cirrhosis.

  Progression of hepatic steatosis or fibrosis to more advanced stages or cirrhosis, as assessed by magnetic resonance imaging and dynamic elastography, using the following evaluation scales: * The hepatic steatosis grading scale based on magnetic resonance imaging-proton density fat fraction (MRI-PDFF); * The hepatic steatosis grading scale based on dynamic elastography using the Controlled Attenuation Parameter (CAP) technique; * The liver fibrosis grading scale assessed by dynamic elastography using liver stiffness (LS) measurement, according to the METAVIR scoring system

  Baseline up to approximately 5 years

Secondary Outcomes (19)

• First-time occurrence of overweight or obesity

  Baseline to approximately 5 years

• First-time occurrence of an increase in visceral adipose tissue

  Baseline to approximately 5 years

• First-time occurrence of Prediabetes or type 2 diabetes mellitus (T2DM)

  Baseline to approximately 5 years

• The assessment of HOMA-IR

  Baseline to approximately 5 years

• First-time occurrence of Pancreatic steatosis

  Baseline to approximately 5 years

Interventions

Trial within cohort (TWIC) OTHER

Educational intervention based on a protocol specifically developed for the TWINS.PL cohort, aimed at activating and engaging the participant in the intervention process. Intervention group: Phenotypically concordant participants from the TWINS.PL STUDY cohort, randomized to receive an educational intervention designed to actively engage them in modifying selected health-relevant endpoints. Control group: The co-twin of the participant randomized to the intervention arm, serving as the control. 1. TWINS-TWIC HL: Research Question: Does participation in a structured, participant-activating educational intervention program influence health literacy indicators among participants of the TWINS.PL study? Study Design: A randomized controlled trial embedded within a prospective observational twin cohort (TWiC study in a twin cohort). 2. TWINS-TWIC DIET Research Question: Does participation in a structured, participant-activating educational intervention focused on dietary habits influence the

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population comprises Polish twin individuals aged 15-44 years, who have provided informed consent, have a living co-twin, and present a positive family history (first- or second-degree relatives) of metabolic syndrome, its related comorbidities, or common complications.

You may qualify if:

• \. 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.

You may not qualify if:

• Co-twin does not consent to participate in the study.
• Inability to obtain medical history of biological family members.
• Presence of advanced liver fibrosis, cirrhosis, or liver cancer.
• Known liver genetic disorders, autoimmune hepatitis, celiac disease, hemochromatosis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), cystic fibrosis, or Wilson's disease.
• Current or chronic alcohol consumption \>20 g of ethanol/day in women and \>30 g/day in men.
• Short bowel syndrome.
• Cyanotic congenital heart defect.
• Myasthenia.
• Central nervous system degenerative diseases such as Alzheimer's disease, Parkinson's disease, or Huntington's disease.
• Storage diseases involving the liver.
• Active malignant neoplasm undergoing treatment (excluding non-melanoma skin cancers and melanoma treated non-pharmacologically).
• Chronic kidney disease requiring renal replacement therapy.
• Status post organ or tissue transplantation requiring immunosuppression.
• Pituitary, hypothalamic, or adrenal hyperfunction/hypofunction requiring hormone supplementation.
• Addiction to psychoactive substances or drugs.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Uniwersytecki Szpital Kliniczny

Poznan, Wielkopolska, 60-355, Poland

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Piotr Eder, MD, Profesor

CONTACT

+(48) 618691343; piotreder@ump.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2033
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)