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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Baseline up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| First-time occurrence of overweight or obesity | Overweight will be defined as a BMI of 25 to <30 kg/m², and obesity as a BMI of ≥30 kg/m² | Baseline to approximately 5 years |
| First-time occurrence of an increase in visceral adipose tissue |
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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:
Temporary exclusion criteria (after resolution, the volunteer may be enrolled):
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Eder, MD, Profesor | Contact | +(48) 618691343 | piotreder@ump.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwersytecki Szpital Kliniczny | Recruiting | Poznan | Wielkopolska | 60-355 | Poland |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Increase in visceral adipose tissue >10%, as assessed by DEXA or BIA
| Baseline to approximately 5 years |
| First-time occurrence of Prediabetes or type 2 diabetes mellitus (T2DM) | First diagnosis of prediabetes or type 2 diabetes mellitus (T2DM), confirmed by standard laboratory criteria (fasting plasma glucose, HbA1c, or oral glucose tolerance test) in accordance with current ADA/EASD guidelines | Baseline to approximately 5 years |
| The assessment of HOMA-IR | First-time occurrence of HOMA-IR >5 | Baseline to approximately 5 years |
| First-time occurrence of Pancreatic steatosis | Visualization of pancreatic steatosis during abdominal ultrasound and/or MRI-PDFF | Baseline to approximately 5 years |
| First-time occurrence of Hypertension (HTN) | Diagnosis of arterial hypertension according to the ESC/ESH definition | Baseline to approximately 5 years |
| First-time occurrence of Acute coronary syndrome, the need for coronary artery bypass grafting (CABG), any percutaneous coronary intervention (PCI), or detection of regional wall motion abnormalities on echocardiography | All outcome events will be confirmed through review of medical records, including hospitalization reports, procedural documentation, and echocardiographic findings, in accordance with the most recent ESC guidelines on Acute Coronary Syndromes. | Baseline to approximately 5 years |
| First-time occurrence of Systolic heart failure with a reduced left ventricular ejection fraction of less than 45% | Diagnosis of systolic heart failure confirmed by echocardiographic assessment showing a left ventricular ejection fraction (LVEF) <45%. | Baseline to approximately 5 years |
| First-time occurrence of Atrial fibrillation/flutter | First documented episode of atrial fibrillation (paroxysmal, persistent, or permanent) or atrial flutter, confirmed by ECG or other cardiac monitoring, or the need for pulmonary vein isolation and/or cavotricuspid isthmus ablation. | Baseline to approximately 5 years |
| First-time occurrence of Requirement for angioplasty, stenting, or surgery of the aorta or any other arteries (excluding trauma-related causes) | First requirement for angioplasty, stent placement, or surgical intervention of the aorta or other arteries (excluding trauma-related procedures), confirmed by medical records and procedural documentation. | Baseline to approximately 5 years |
| First-time occurrence of Implantation of a cardiac electronic device | First implantation of a cardiac electronic device (e.g., pacemaker, ICD, or CRT) indicated for sick sinus syndrome, advanced atrioventricular conduction abnormalities, or ischemic heart disease, as confirmed by procedural documentation. | Baseline to approximately 5 years |
| First-time occurrence of Transient ischemic attack (TIA) or ischemic stroke | First documented occurrence of transient ischemic attack (TIA) or ischemic stroke, confirmed by neurological assessment and/or neuroimaging, in accordance with current ESC guidelines. | Baseline to approximately 5 years |
| First-time occurrence of Hashimoto's thyroiditis | Increase of at least one anti-thyroid autoantibody - anti-thyroid peroxidase and/or anti-thyroglobulin, accompanied by typical ultrasound picture suggesting Hashimoto's thyroiditis, namely irregular, decreased echogenicity of thyroid parenchyma, signs of fibrosis and decreased vascularity on Color Doppler examination | Baseline to approximately 5 years |
| First-time occurrence of Focal thyroid lesions detected on ultrasound | Focal thyroid lesions detected on ultrasound (≥1 lesion with a diameter >5 mm) | Baseline to approximately 5 years |
| First-time occurrence of Adrenal incidentaloma | Adrenal lesion >10 mm in diameter | Baseline to approximately 5 years |
| First-time occurrence of Malignancy with a known potential association with insulin resistance | e.g., colorectal, thyroid, breast, endometrial, hepatic, pancreatic, renal, gallbladder, esophageal, or ovarian cancer | Baseline to approximately 5 years |
| First-time occurrence of Long COVID-19 syndrome | Defined as persistent (over 12 weeks) symptoms (listed in the questionnaire filled out by the patient), which appeared after COVID-19 infection and their occurrence cannot be explained by other causes | Baseline to approximately 5 years |
| Death from non-accidental causes | The number of deaths from non accidental causes during the observation period | Baseline to approximately 5 years |
| The assessment of HbA1c | First-time occurrence of HbA1c >5.7% | Baseline to approximately 5 years |
| D009750 |
| Nutritional and Metabolic Diseases |