Status:
RECRUITING
Metabolic Syndrome Among Polish Twins
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
Twins
Metabolic Syndrome
Eligibility:
All Genders
15-44 years
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...
Eligibility Criteria
Inclusion
- 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:
- 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.
- Other severe and incurable diseases that, in the investigator's opinion, constitute a permanent contraindication for participation in the study.
- Lack of cooperation by the volunteer during the visit to the Research Center. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
- Temporary exclusion criteria (after resolution, the volunteer may be enrolled):
- 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.
- Any vaccination within the past 6 weeks.
- Pregnancy and up to 6 months postpartum.
- 3 months after the natural cessation of breastfeeding.
- 3 months after surgery (does not apply to minor surgical procedures).
- Untreated hyperthyroidism or hypothyroidism - inclusion possible 3 months after achieving euthyroidism.
- Significant weight loss or gain in the past 3 months (\>10% of initial body weight) - inclusion possible 3 months after weight stabilization.
- 6 months after discontinuation of temporary parenteral or enteral nutrition via feeding tube.
- 12 months after bariatric surgery.
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2033
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT07181018
Start Date
September 1 2025
End Date
September 30 2033
Last Update
September 18 2025
Active Locations (1)
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1
Uniwersytecki Szpital Kliniczny
Poznan, Wielkopolska, Poland, 60-355