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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome; Normal Weight Obesity; Metabolically Obese Normal Weight

Detailed Description

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):

1. MONW Group: BMI < 25 kg/m² and PBF ≥ 35.78% (threshold derived from pilot population studies).
2. 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.

1. 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.
2. 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.

3. 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.

4. 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).
5. 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.

• Study Type: Observational
• Enrollment (Estimated): 176

Contacts and Locations

• Study Contact: Name: Waldemar Pluta, Msc; Phone Number: +48 91 4800 988; Email: waldemar.pluta@pum.edu.pl
• Study Contact Backup: Name: Anna Lubkowska, PhD, Prof.; Phone Number: +48 91 81 06 261; Email: anna.lubkowska@pum.edu.pl

Study Locations

• Poland
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 70-204
      • Pomeranian Medical University in Szczecin
      • Contact: Anna Lubkowska, PhD, Prof.; Phone Number: +48 91 81 06 261; Email: anna.lubkowska@pum.edu.pl
      • Contact: Waldemar Wojciech Pluta, Msc; Phone Number: +48 91 4800 988; Email: waldemar.pluta@pum.edu.pl
      • Principal Investigator: Waldemar Pluta, Msc
      • Sub-Investigator: Anna Lubkowska, PhD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MONW Group; Women with normal BMI (<25 kg/m²) and excessive body fat percentage (PBF ≥ 35.78%).
Control Group; Women with normal BMI (<25 kg/m²) and normal body fat percentage (PBF < 35.78%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Asprosin Concentration	Concentration of asprosin measured in serum using the ELISA method (Enzyme-Linked Immunosorbent Assay).	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Collaborators: National Science Centre, Poland
• Investigators: Principal Investigator: Waldemar Pluta, Msc, Pomeranian Medical University in Szczecin; Study Director: Anna Lubkowska, PhD, Prof., Pomeranian Medical University in Szczecin

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Metabolomics; Endothelial Dysfunction; Flow-Mediated Dilation; Visceral Adiposity; Metabolic Disorders; Normal Weight; Asprosin
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Glucose Metabolism Disorders; Musculoskeletal Abnormalities; Congenital Abnormalities; Insulin Resistance; Hyperinsulinism; Limb Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Metabolic Syndrome; Metabolic Diseases; Arachnodactyly
• Other Study ID Numbers: Preludium 2024 - 02387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Open access without restrictions. Data will be freely available to any researcher or the public for any purpose immediately upon publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No