ClinicalTrials.gov record NCT07358533

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 35 years old
SexFemale
LocationPoland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study will enroll 176 healthy women aged 18–35 with normal BMI to look for signs of metabolically obese normal-weight (MONW) physiology. Participants are split into two groups by body fat percentage measured by DXA and assessed at baseline and after 12 months. Tests include body composition (DXA), brachial artery flow-mediated dilation (FMD) ultrasound, fasting blood draws for biochemical markers and hormones, and metabolomic profiling on a subset. Questionnaires about diet and activity are also collected.

What it is studying. The study is testing how excess body fat (despite normal BMI), vascular endothelial function, and blood levels of asprosin and other markers relate in young women, and whether a combination of measures can serve as diagnostic markers of the MONW phenotype.

What the researchers hope to learn. To identify diagnostic markers (including asprosin and metabolomic signatures) and vascular measures associated with the MONW phenotype, and to build predictive models for early cardiovascular risk detection in normal-weight individuals.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would attend a baseline visit and a 12‑month follow-up, both scheduled in the early follicular phase of the menstrual cycle (days 3–7); before each visit you must fast at least 12 hours and avoid caffeine, smoking, and strenuous exercise for 24 hours. At each visit you will have body measurements (height, weight, waist/hip), a whole-body DXA scan to measure total and visceral fat, and a fasting blood draw for biochemical, hormonal, and metabolomic testing (a subset of samples will undergo advanced metabolomic profiling). Vascular function will be assessed by flow‑mediated dilation (FMD), an ultrasound test of the brachial artery that includes a 5‑minute cuff occlusion and post‑occlusion imaging. You will also complete standardized questionnaires about physical activity and diet; study data will be pseudonymized and stored securely.

How the study is structured. A prospective observational cohort: 176 women are assigned to MONW or control groups based on percent body fat by DXA (threshold 35.78%). Each participant has a baseline visit and a 12‑month follow-up. Visits are timed to the early follicular menstrual phase; participants fast for 12 hours and avoid caffeine, smoking, and heavy exercise for 24 hours before visits. Procedures include anthropometric measures, whole-body DXA, brachial artery FMD ultrasound (pre-occlusion imaging, 5-minute cuff occlusion, post-occlusion imaging), fasting blood draws for metabolic and hormonal tests, and targeted/untargeted metabolomics on a subset. Data and questionnaires are pseudonymized and stored securely.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Normal Weight Obesity; Metabolically Obese Normal Weight; Metabolic Syndrome. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Poland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
September 2026 (estimated)
Primary completion
May 2027 (estimated)
Study completion
September 2029 (estimated)
Target enrollment
176 participants (estimated)
Last updated on registry
Jan 23, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Pomeranian Medical University Szczecin
Principal investigator
Waldemar Pluta, Principal Investigator
Pomeranian Medical University Szczecin
Collaborators
  • National Science Centre, Poland

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Control group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Allocation
How participants are assigned to study groups, for example at random or by a non-random rule.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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