An observational study in Normal Weight Obesity, Metabolically Obese Normal Weight and Metabolic Syndrome, sponsored by Pomeranian Medical University Szczecin. Not yet recruiting at 1 site in Poland. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Pomeranian Medical University Szczecin · Observational
Metabolically Obese Normal Weight (MONW) represents a phenotype affecting individuals with a normal Body Mass Index (BMI) but characterized by excessive adipose tissue accumulation. This condition is associated with increased cardiovascular risk, insulin resistance, and endothelial dysfunction, yet remains underdiagnosed.
This observational longitudinal study aims to comprehensively evaluate the relationship between excessive adipose tissue deposition, endothelial dysfunction, and asprosin concentrations in young women. The study will recruit 176 healthy women aged 18-35 years with normal BMI (\<25 kg/m²). Participants will be divided into two groups based on body fat percentage (PBF) assessed by dual-energy X-ray absorptiometry (DXA): the MONW group (PBF ≥ 35.78%) and the Control group (PBF \< 35.78%).
The specific objectives of the study include:
Participants will undergo anthropometric measurements, body composition analysis (DXA), and blood sampling for biochemical and hormonal analyses. The study aims to develop predictive models for early cardiovascular risk detection in normal-weight individuals.
Study Design and Population:
This is a longitudinal observational study involving 176 healthy women aged 18-35 years. The primary aim is to identify diagnostic markers for Metabolically Obese Normal Weight (MONW) individuals. Recruitment is conducted via digital prescreening and university networks. Eligible participants must have a normal BMI (18.5-24.9 kg/m²) and stable body weight.
Group Allocation:
Participants will be divided into two groups based on Body Fat Percentage (PBF) assessed by Dual-Energy X-ray Absorptiometry (DXA):
Study Procedures:
The study involves a baseline visit and a follow-up visit after 12 months.
Endothelial Function Assessment (FMD): Flow-mediated dilation of the brachial artery is measured using high-resolution ultrasound (Alpinion Xcube 90, linear probe L3-12). The protocol includes:
Biochemical Analysis: Fasting blood samples are collected for:
Data Collection:
Participants also complete standardized questionnaires regarding physical activity (IPAQ) and dietary habits (62-item FFQ-6, KomPAN). All data is pseudonymized and stored on a secured server.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 176 is below the median of 197 across 496 observational studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Pomeranian Medical University Szczecin is the lead sponsor of 69 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy women aged 18-35 years with a normal body weight (BMI \<25 kg/m²) recruited from the West Pomeranian region (Poland).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with normal BMI (\<25 kg/m²) and excessive body fat percentage (PBF ≥ 35.78%).
Women with normal BMI (\<25 kg/m²) and normal body fat percentage (PBF \< 35.78%).
Brachial Artery Flow-Mediated Dilation (FMD)
Assessment of vascular endothelial function using high-resolution ultrasound (Alpinion Xcube 90). FMD is calculated as the percentage change in vessel diameter from baseline to peak dilation following 5-minute occlusion cuff release.
Time frame: Baseline, 12 months
Serum Asprosin Concentration
Concentration of asprosin measured in serum using the ELISA method (Enzyme-Linked Immunosorbent Assay).
Time frame: Baseline, 12 months
Plan to share: Yes — All individual participant data (IPD) that underlie results in a publication will be shared. This includes anonymized data sets containing: anthropometric measurements (including DXA body composition), vascular endothelial function parameters (FMD), biochemical and hormonal analysis results (including asprosin, ADMA, vWF), metabolomic profiles (LC-MS/MS), and responses from dietary and physical activity questionnaires.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available beginning at the time of publication of the associated article and will be stored for at least 10 years.
Access criteria: Open access without restrictions. Data will be freely available to any researcher or the public for any purpose immediately upon publication.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.
Of 149 non-industry observational studies under Metabolic Syndrome, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 106. This study's planned 8 months is below that.
Counting every sponsor, half of 160 studies reached it within 42 months; a quarter within 18 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Pomeranian Medical University Szczecin