Pomeranian Medical University in Szczecin
Szczecin, West Pomeranian Voivodeship, 70-204, Poland
NCT Number: NCT07358533
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.
Trial opening soon.
Get Notified18 year–35 year
Female
Observational
Szczecin, West Pomeranian Voivodeship, 70-204, Poland
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Baseline, 12 months
Concentration of asprosin measured in serum using the ELISA method (Enzyme-Linked Immunosorbent Assay).
Trial opening soon.
Get NotifiedPomeranian Medical University Szczecin
Other
Disorders Hidden Under the Guise of BMI - Metabolic Obesity in People With Normal Body Weight (MONW) - the Search for Diagnostic Markers and Its Consequences for Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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