TwinsTWINSPLNCT07181018
Metabolic Syndrome Among Polish Twins
An observational study of Twins and Metabolic Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 44 years
- Conditions the study is for
- Twins, Metabolic Syndrome
- What is being tested?
- Trial within cohort (TWIC)
- How many people
- 1,500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2025to 30 Sep 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny
Poznan, Wielkopolska, 60-355
Piotr Eder, MD PhD, +48618691526, piotreder@ump.edu.pl
Przemyslaw Guzik, MD PhD, +48618691638, pguzik@ump.edu.pl
About this study
Official title: Multimorbidity in Metabolic Syndrome: A Longitudinal Cohort Study in TWINS.PL
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:
- 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.
- 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.
- 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.
- To evaluate the prevalence of malignancies in a young twin population (aged 15-44 years) with MS or with risk factors for MS.
- 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.
- 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
- Being tested
- Trial within cohort (TWIC)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
- 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).
- TWINS-TWIC DIET Research Question: Does participation in a structured, participant-activating educational intervention focused on dietary habits influence the
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline up to approximately 5 years
Secondary outcomes (19)
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
Measured: Baseline to approximately 5 years
First-time occurrence of an increase in visceral adipose tissue
Increase in visceral adipose tissue >10%, as assessed by DEXA or BIA
Measured: 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
Measured: Baseline to approximately 5 years
The assessment of HOMA-IR
First-time occurrence of HOMA-IR >5
Measured: Baseline to approximately 5 years
First-time occurrence of Pancreatic steatosis
Visualization of pancreatic steatosis during abdominal ultrasound and/or MRI-PDFF
Measured: Baseline to approximately 5 years
First-time occurrence of Hypertension (HTN)
Diagnosis of arterial hypertension according to the ESC/ESH definition
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Baseline to approximately 5 years
First-time occurrence of Adrenal incidentaloma
Adrenal lesion >10 mm in diameter
Measured: 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
Measured: 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
Measured: Baseline to approximately 5 years
Death from non-accidental causes
The number of deaths from non accidental causes during the observation period
Measured: Baseline to approximately 5 years
The assessment of HbA1c
First-time occurrence of HbA1c >5.7%
Measured: Baseline to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TwinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181018
- Sponsor's protocol ID
- 2023/ABM/03/00048
- Acronym
- TWINSPL
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimorbidity in Metabolic Syndrome: A Longitudinal Cohort Study in TWINS.PL
- ClinicalTrials.gov ID
- NCT07181018
- Acronym / sponsor ID
- TWINSPL / 2023/ABM/03/00048
- Conditions
- Twins, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- To evaluate the prevalence of malignancies in a young twin population (aged 15-44 years) with MS or with risk factors for MS.
- 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.
- To assess the role of genetic and environmental components in the occurrence and severity of MS phenotype discordance in monozygotic twins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 15 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trial within cohort (TWIC)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 | Other | – |
Primary outcome
De novo occurrence of metabolic steatosis, hepatic fibrosis, or cirrhosis.
Time frame: Baseline up to approximately 5 years
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.
Progression of hepatic steatosis or fibrosis to more advanced stages or cirrhosis.
Time frame: Baseline up to approximately 5 years
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
19 secondary outcomes
First-time occurrence of overweight or obesity
Time frame: Baseline to approximately 5 years
First-time occurrence of an increase in visceral adipose tissue
Time frame: Baseline to approximately 5 years
First-time occurrence of Prediabetes or type 2 diabetes mellitus (T2DM)
Time frame: Baseline to approximately 5 years
The assessment of HOMA-IR
Time frame: Baseline to approximately 5 years
First-time occurrence of Pancreatic steatosis
Time frame: Baseline to approximately 5 years
First-time occurrence of Hypertension (HTN)
Time frame: 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
Time frame: Baseline to approximately 5 years
First-time occurrence of Systolic heart failure with a reduced left ventricular ejection fraction of less than 45%
Time frame: Baseline to approximately 5 years
First-time occurrence of Atrial fibrillation/flutter
Time frame: 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)
Time frame: Baseline to approximately 5 years
First-time occurrence of Implantation of a cardiac electronic device
Time frame: Baseline to approximately 5 years
First-time occurrence of Transient ischemic attack (TIA) or ischemic stroke
Time frame: Baseline to approximately 5 years
First-time occurrence of Hashimoto's thyroiditis
Time frame: Baseline to approximately 5 years
First-time occurrence of Focal thyroid lesions detected on ultrasound
Time frame: Baseline to approximately 5 years
First-time occurrence of Adrenal incidentaloma
Time frame: Baseline to approximately 5 years
First-time occurrence of Malignancy with a known potential association with insulin resistance
Time frame: Baseline to approximately 5 years
First-time occurrence of Long COVID-19 syndrome
Time frame: Baseline to approximately 5 years
Death from non-accidental causes
Time frame: Baseline to approximately 5 years
The assessment of HbA1c
Time frame: Baseline to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twins and Metabolic Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Eder, MD, Profesor (+(48) 618691343, piotreder@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
De novo occurrence of metabolic steatosis, hepatic fibrosis, or cirrhosis. (time frame: Baseline up to approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.