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

NCT07358533 | Not Yet Recruiting

• 1 other identifier: Preludium 2024 - 02387
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal Weight Obesity; Metabolically Obese Normal Weight; Metabolic Syndrome

Keywords

Endothelial Dysfunction; Metabolic Disorders; Visceral Adiposity; Flow-Mediated Dilation; Metabolomics; Asprosin; Normal Weight

Outcome Measures

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.

  Baseline, 12 months

Secondary Outcomes (1)

• Serum Asprosin Concentration

  Baseline, 12 months

Study Arms (2)

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%).

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• Written, informed consent to participate in the research.
• Gender: Female.
• Age 18-35 years.
• BMI in the range of 18.5-25 kg/m².

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

Pomeranian Medical University in Szczecin

Szczecin, West Pomeranian Voivodeship, 70-204, Poland

Location

MeSH Terms

Conditions

Metabolic Syndrome; Metabolic Diseases; Arachnodactyly

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Waldemar Pluta, Msc

  Pomeranian Medical University in Szczecin

  PRINCIPAL INVESTIGATOR

• Anna Lubkowska, PhD, Prof.

  Pomeranian Medical University in Szczecin

  STUDY DIRECTOR

Central Study Contacts

Waldemar Pluta, Msc

CONTACT

+48 91 4800 988; waldemar.pluta@pum.edu.pl

Anna Lubkowska, PhD, Prof.

CONTACT

+48 91 81 06 261; anna.lubkowska@pum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Open access without restrictions. Data will be freely available to any researcher or the public for any purpose immediately upon publication.

Locations

PL (1)