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NCT Number: NCT07358533

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Pomeranian Medical University in Szczecin

Szczecin, West Pomeranian Voivodeship, 70-204, Poland

Location contact

Anna Lubkowska, PhD, Prof.

CONTACT

[email protected]

+48 91 81 06 261

Anna Lubkowska, PhD, Prof.

SUB_INVESTIGATOR

Waldemar Pluta, Msc

PRINCIPAL_INVESTIGATOR

Waldemar Wojciech Pluta, Msc

CONTACT

[email protected]

+48 91 4800 988

About this study

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):

  • MONW Group: BMI < 25 kg/m² and PBF ≥ 35.78% (threshold derived from pilot population studies).
  • Control Group: BMI < 25 kg/m² and PBF < 35.78%.

Study Procedures:

The study involves a baseline visit and a follow-up visit after 12 months.

  • Standardization: Visits are scheduled during the early follicular phase of the menstrual cycle (days 3-7) to minimize hormonal variability affecting endothelial function. Participants must fast for at least 12 hours and abstain from caffeine, smoking, and strenuous exercise for 24 hours prior.
  • Anthropometry and Body Composition: Height, weight, and circumferences (waist, hip) are measured. Whole-body composition is analyzed using DXA (Hologic QDR 4500W) to determine total and visceral fat mass.
  • 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:
  • 1-minute baseline imaging.
  • 5-minute occlusion (cuff inflation to 250 mmHg).
  • 3-minute continuous post-occlusion imaging to assess peak diameter.
  • Biochemical Analysis: Fasting blood samples are collected for:
  • Lipid profile (TC, LDL, HDL, TG) and glucose metabolism markers (glucose, insulin, HbA1c).
  • ELISA quantification of specific biomarkers: Asprosin, Asymmetric Dimethylarginine (ADMA), von Willebrand Factor (vWF), and sex hormones (Estradiol, Testosterone, SHBG).
  • Metabolomics: Targeted and untargeted metabolomic profiling (LC-MS/MS) is performed on a subset of plasma samples to identify metabolic signatures associated with the MONW phenotype.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Brachial Artery Flow-Mediated Dilation (FMD)

    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.

Secondary outcomes

  1. Serum Asprosin Concentration

    Time frame: Baseline, 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Lubkowska, PhD, Prof.

CONTACT

[email protected]

+48 91 81 06 261

Waldemar Pluta, Msc

CONTACT

[email protected]

+48 91 4800 988

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Collaborators

  • National Science Centre, Poland

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jan 22, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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