Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07358533

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 35 Years
SexFemale
Healthy volunteersAccepted
ConditionNormal Weight Obesity, Metabolically Obese Normal Weight, Metabolic Syndrome

Full registry criteria

Inclusion Criteria: * Written, informed consent to participate in the research. * Gender: Female. * Age 18-35 years. * BMI in the range of 18.5-25 kg/m². Exclusion Criteria: * Thyroid disease. * Pregnancy or breastfeeding. * Eating disorders. * Polycystic ovary syndrome (PCOS). * Hormone therapy and/or use of hormonal contraceptives. * Smoking. * Metal or silicone implants (contraindication for DXA/body composition accuracy). * Vitamin and/or mineral supplementation. * Acute and/or chronic illnesses. * Type I or II diabetes, dyslipidemia, hypertension. * Use of hypolipemic, antihypertensive, antiglycemic, or insulin medications.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Brachial Artery Flow-Mediated Dilation (FMD)Baseline, 12 months

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Pomeranian Medical University in Szczecin🇵🇱 Szczecin, West Pomeranian Voivodeship, Poland
Waldemar Wojciech Pluta, MscContact
Anna Lubkowska, PhD, Prof.Contact
Waldemar Pluta, MscPrincipal Investigator