Metabolic Obesity in Normal Weight (MONW): Diagnostic Markers Stud

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorPomeranian Medical University Szczecin

About this trial

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:

* Assessment of vascular endothelial function using flow-mediated dilation (FMD) of the brachial artery. * Evaluation of asprosin as a novel biomarker in the MONW phenotype. * Analysis of biochemical indices including asymmetric dimethylarginine (ADMA) and von Willebrand factor (vWF). * Advanced metabolomic profiling to identify metabolic signatures.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Written, informed consent to participate in the research.

Gender: Female.

Age 18-35 years.

BMI in the range of 18.5-25 kg/m².

Disqualifiers

Thyroid disease.

Pregnancy or breastfeeding.

Eating disorders.

Polycystic ovary syndrome (PCOS).

Trial population

Healthy women aged 18-35 years with a normal body weight (BMI \<25 kg/m²) recruited from the West Pomeranian region (Poland).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

176 Participants
are grouped into 2 trial groups
Group A: MONW Group
Group B: Control Group

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Serum Asprosin Concentration

Concentration of asprosin measured in serum using the ELISA method (Enzyme-Linked Immunosorbent Assay).

Time frame
Baseline, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pomeranian Medical University Szczecin

Lead sponsor

National Science Centre, Poland

Collaborator

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