Normal Weight ObesityNCT07358533
Metabolic Obesity in Normal Weight (MONW): Diagnostic Markers Stud
An observational study of Normal Weight Obesity and Metabolically Obese Normal Weight, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Weight Obesity, Metabolically Obese Normal Weight, Metabolic Syndrome
- How many people
- 176 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2026to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women aged 18-35 years with a normal body weight (BMI <25 kg/m²) recruited from the West Pomeranian region (Poland).
Who may be able to join
- Written, informed consent to participate in the research.
- Gender: Female.
- Age 18-35 years.
- BMI in the range of 18.5-25 kg/m².
Who cannot join
- Thyroid disease.
- Pregnancy or breastfeeding.
- Eating disorders.
- Polycystic ovary syndrome (PCOS).
- Hormone therapy and/or use of hormonal contraceptives.
- Smoking.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Pomeranian Medical University in Szczecin
Szczecin, West Pomeranian Voivodeship, 70-204
Waldemar Wojciech Pluta, Msc, +48 91 4800 988, waldemar.pluta@pum.edu.pl
Anna Lubkowska, PhD, Prof., +48 91 81 06 261, anna.lubkowska@pum.edu.pl
About this study
Official 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
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%).
Read more
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.
Read the 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):
- 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.
- Keywords
- Endothelial Dysfunction, Metabolic Disorders, Visceral Adiposity, Flow-Mediated Dilation, Metabolomics, Asprosin, Normal Weight
- Medical subject headings
- Metabolic Syndrome, Metabolic Diseases, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 months
Secondary outcomes (1)
Serum Asprosin Concentration
Concentration of asprosin measured in serum using the ELISA method (Enzyme-Linked Immunosorbent Assay).
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Weight ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Principal investigator, Waldemar Pluta, Pomeranian Medical University Szczecin
- Investigators
- Waldemar Pluta, Msc, Principal investigator, Pomeranian Medical University in SzczecinAnna Lubkowska, PhD, Prof., Study director, Pomeranian Medical University in Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358533
- Sponsor's protocol ID
- Preludium 2024 - 02387
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07358533
- Acronym / sponsor ID
- Preludium 2024 - 02387
- Keywords
- Endothelial Dysfunction, Metabolic Disorders, Visceral Adiposity, Flow-Mediated Dilation, Metabolomics, Asprosin, Normal Weight
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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):
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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%). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women aged 18-35 years with a normal body weight (BMI <25 kg/m²) recruited from the West Pomeranian region (Poland).
Key inclusion criteria (4 listed)
- Written, informed consent to participate in the research.
- Gender: Female.
- Age 18-35 years.
- BMI in the range of 18.5-25 kg/m².
Key exclusion criteria (11 listed)
- Thyroid disease.
- Pregnancy or breastfeeding.
- Eating disorders.
- Polycystic ovary syndrome (PCOS).
- Hormone therapy and/or use of hormonal contraceptives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Serum Asprosin Concentration
Time frame: Baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Waldemar Pluta, Msc principal investigator
Pomeranian Medical University in Szczecin
Anna Lubkowska, PhD, Prof. study director
Pomeranian Medical University in Szczecin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Weight Obesity and Metabolically Obese Normal Weight, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waldemar Pluta, Msc (+48 91 4800 988, waldemar.pluta@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Flow-Mediated Dilation (FMD) (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.