Metabolic SyndromeASPRO-MetSNCT07917364
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
An observational study of Metabolic Syndrome and Insulin Resistance, run by University of Applied Sciences in Nowy Targ at 1 site in Poland.
Trial summary
Metabolic syndrome is a major risk factor for cardiovascular disease and type 2 diabetes, and its prevalence in young adults is increasing. Early identification of individuals at risk may improve prevention strategies. 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
- Metabolic Syndrome, Insulin Resistance, Obesity, Abdominal
- What is being tested?
- Biomarker panel (asprosin, microRNA, BDNF, cortisol) and Clinical and questionnaire assessment
- How many people
- 110 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2026to Mar 2027
- 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: Women aged 18 to 35 years recruited from the general and academic population of the Podhale region and the Malopolska Province, Poland, through university websites, e-mail, social media, local press, printed posters and leaflets, and information meetings. Eligibility is screened using an online questionnaire. Enrolled participants form two equally sized groups: women diagnosed with metabolic syndrome according to NCEP ATP III criteria and healthy women of comparable age.
Who may be able to join
- Female sex
- Age 18 to 35 years
- Regular menstrual cycle
- Not engaged in competitive sports training in any discipline
- Non-smoker
- No alcohol abuse
- No continuous pharmacotherapy, with the exception of treatment for diabetes and/or antihypertensive treatment; no use of hormonal contraception
- Written informed consent for study participation and processing of personal data
Who cannot join
- Age outside the range of 18 to 35 years
- Irregular menstrual cycle
- Pregnancy or breastfeeding
- Continuous pharmacotherapy for indications other than diabetes and/or hypertension, including any form of hormonal contraception (oral, transdermal, vaginal, implant, injectable or intrauterine)
- Competitive sports training in any discipline
- Current smoking
- Alcohol abuse
- Lack of written informed consent for study participation and processing of personal data
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, 1 recruiting
- Recruiting
Institute of Medicine, University of Applied Sciences in Nowy Targ, Kokoszków 71, 34-400 Nowy Targ, Poland
Nowy Targ, Lesser Poland Voivodeship, 34-400
Małgorzata Kantorowicz, Ph.D., +48 662 251 012, malgorzata.kantorowicz@ans-nt.edu.pl
Kamil Opar, Master's degree, +48 603442732, kamil.opar@ans-nt.edu.pl
About this study
Official title: Association Between Serum Asprosin Concentration and Expression of Selected miRNAs With Risk Factors and Components of Metabolic Syndrome in Young Women: Diagnostic Perspectives
Metabolic syndrome is a major risk factor for cardiovascular disease and type 2 diabetes, and its prevalence in young adults is increasing. Early identification of individuals at risk may improve prevention strategies. This observational, cross-sectional case-control study investigates the relationship between serum asprosin concentration, the expression of six selected circulating microRNAs, and the components and risk factors of metabolic syndrome in young women aged 18 to 35 years. Two equally sized groups will be compared: women meeting NCEP ATP III criteria for metabolic syndrome and healthy age-matched controls. Participants attend a single study visit during which fasting blood samples, anthropometric and body composition measurements, blood pressure, and validated questionnaires assessing physical activity, diet, sleep quality, perceived stress, and quality of life are collected. The study aims to determine whether asprosin and the selected microRNA profile have diagnostic value as biomarkers of metabolic syndrome in this population.
Read the detailed description
Background. Metabolic syndrome is a complex disorder characterized by the coexistence of abdominal obesity, hypertension, dyslipidemia, and impaired glucose metabolism, resulting in an increased risk of cardiovascular disease and type 2 diabetes mellitus. Although established diagnostic criteria exist, there is an ongoing need for novel biomarkers that may improve early detection and clarify the pathophysiological mechanisms involved, particularly in young adults, in whom the condition remains under-investigated.
Asprosin is a fasting-induced adipokine implicated in glucose metabolism, insulin resistance, and obesity. Circulating microRNAs are considered promising molecular biomarkers involved in metabolic regulation and inflammatory pathways. Brain-derived neurotrophic factor (BDNF) and cortisol are additional candidate mediators linking metabolic, psychological, and sleep-related factors.
Objectives. The primary objective is to determine whether serum asprosin concentration and the expression of six selected circulating microRNAs (miR-15a-5p, miR-197-3p, miR-23a-3p, miR-21-5p, miR-146a-5p, miR-223-3p) differ between young women with metabolic syndrome and healthy age-matched women. Secondary objectives are to compare the prevalence of individual metabolic syndrome components, body composition, anthropometric, insulin resistance and atherogenic indices, physical activity, diet, sleep quality, perceived stress, and health-related quality of life between the groups, and to assess correlations between asprosin, the microRNA profile, and these variables.
Design and participants. A total of 110 women aged 18 to 35 years will be enrolled into two equally sized groups: women with metabolic syndrome without other comorbidities requiring continuous pharmacotherapy (MetS, n=55) and healthy women (CON, n=55). Sample size was calculated using G*Power 3.1.9.7; assuming a two-tailed independent-samples comparison, alpha = 0.05, effect size d = 0.5, and power = 0.80, the minimum required sample is 51 participants per group. Recruitment is continuous and conducted among young women in the Podhale region and the Malopolska Province, primarily in the academic community.
Procedures. Eligibility is screened via an online form. Eligible participants attend a single study visit of approximately 90 minutes at the Institute of Medicine of the University of Applied Sciences in Nowy Targ. After written informed consent, the following are performed: fasting venous blood collection (18 mL, antecubital vein, vacuum system, by qualified medical personnel); blood pressure measurement; anthropometric measurements (body height, body mass, waist, abdominal and hip circumference) and body composition assessment by bioelectrical impedance analysis (BIA); and completion of validated questionnaires - International Physical Activity Questionnaire (IPAQ) and 7-day Physical Activity Recall (7day-PAR), Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10), Food Frequency Questionnaire (FFQ) or KomPAN together with the Fitatu dietary application, and the Short Form-36 Health Survey (SF-36).
Laboratory analyses performed immediately in a certified external laboratory: complete blood count, fasting glucose, glycated hemoglobin, insulin, and lipid profile. Plasma is separated by centrifugation at 2500 RCF for 15 minutes, aliquoted, and stored at -80 degrees C until batch analysis of asprosin, BDNF, cortisol, and the microRNA panel.
Metabolic syndrome diagnosis. Made by a physician according to NCEP ATP III criteria for women, requiring at least three of five components: triglycerides greater than 150 mg/dL; HDL cholesterol below 50 mg/dL; blood pressure greater than 130/85 mmHg or antihypertensive treatment; fasting glucose greater than 100 mg/dL or previously diagnosed diabetes; waist circumference greater than 88 cm.
Derived indices. BMI, WHR, WHtR, A Body Shape Index (ABSI), Hip Index (HI), Body Adiposity Index (BAI), Visceral Adiposity Index (VAI), Lipid Accumulation Product (LAP), HOMA-IR, QUICKI, METS-IR, triglyceride-glucose index (TyG), Castelli Risk Index I and II (CRI-I, CRI-II), and Atherogenic Index of Plasma (AIP).
Statistical analysis. Distribution of variables will be assessed using the Shapiro-Wilk test. Between-group comparisons will use the independent-samples t-test or the Mann-Whitney U test as appropriate. Correlations will be assessed using Pearson or Spearman coefficients. Statistical significance will be set at p less than 0.05.
All participants will receive their individual results. Data will be anonymized before analysis and scientific use.
- Being tested
- Biomarker panel (asprosin, microRNA, BDNF, cortisol), Clinical and questionnaire assessment
- Keywords
- Asprosin, microRNA, miRNA, Biomarkers, Young Women, Insulin Resistance, Cardiometabolic Risk, BDNF, Cortisol, Sleep Quality, Perceived Stress, NCEP ATP III, Body Composition
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Obesity, Abdominal, Dyslipidemias, Arachnodactyly, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker panel (asprosin, microRNA, BDNF, cortisol)Diagnostic test
Fasting venous blood collection for measurement of serum asprosin, BDNF and cortisol concentrations, and expression of six circulating microRNAs (miR-15a-5p, miR-197-3p, miR-23a-3p, miR-21-5p, miR-146a-5p, miR-223-3p), in addition to complete blood count, glucose, glycated hemoglobin, insulin, and lipid profile.
Clinical and questionnaire assessmentOther
Blood pressure measurement, anthropometric measurements and bioelectrical impedance body composition analysis, and completion of validated questionnaires (IPAQ, 7day-PAR, PSQI, PSS-10, FFQ/KomPAN with the Fitatu application, SF-36).
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Syndrome Group (MetS) | Women aged 18-35 years meeting NCEP ATP III criteria for metabolic syndrome (at least three of five components: triglycerides greater than 150 mg/dL; HDL cholesterol below 50 mg/dL; blood pressure greater than 130/85 mmHg or antihypertensive treatment; fasting glucose greater than 100 mg/dL or previously diagnosed diabetes; waist circumference greater than 88 cm), with no other comorbidity requiring continuous pharmacotherapy. Target n=55. Receives: Diagnostic Test: Biomarker panel (asprosin, microRNA, BDNF, cortisol); Other: Clinical and questionnaire assessment | |
| Control Group (CON) | Healthy women aged 18-35 years not meeting NCEP ATP III criteria for metabolic syndrome, matched for age, not receiving continuous pharmacotherapy. Target n=55. Receives: Diagnostic Test: Biomarker panel (asprosin, microRNA, BDNF, cortisol); Other: Clinical and questionnaire assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum asprosin concentration
Fasting serum asprosin concentration measured by enzyme-linked immunosorbent assay, compared between women with metabolic syndrome and healthy controls. Reported in ng/mL.
Measured: At the single study visit (Day 1)
Expression of selected circulating microRNAs
Relative expression of six circulating microRNAs (miR-15a-5p, miR-197-3p, miR-23a-3p, miR-21-5p, miR-146a-5p, miR-223-3p) quantified in plasma by reverse-transcription quantitative PCR. Expression is normalized using ath-miR159a as an exogenous spike-in control and hsa-miR-186-5p as a reference. All six analytes are measured by the same method and reported in the same unit of measure, relative fold change, with results reported separately for each microRNA.
Measured: At the single study visit (Day 1)
Secondary outcomes (20)
Prevalence of individual metabolic syndrome components
Proportion of participants in each group meeting each of the five NCEP ATP III components: elevated triglycerides, reduced HDL cholesterol, elevated blood pressure, elevated fasting glucose, and abdominal obesity. Reported as percentage of participants.
Measured: At the single study visit (Day 1)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR calculated from fasting glucose and fasting insulin as (fasting insulin in microU/mL x fasting glucose in mg/dL) / 405, compared between the metabolic syndrome group and the control group. Reported as an index score (unitless). Higher values indicate greater insulin resistance.
Measured: At the single study visit (Day 1)
Castelli Risk Index I
Ratio of total cholesterol to HDL cholesterol, calculated from the fasting lipid profile and compared between the metabolic syndrome group and the control group. Reported as a ratio (unitless). Higher values indicate greater atherogenic risk.
Measured: At the single study visit (Day 1)
Body fat percentage
Body fat percentage (PBF) measured by bioelectrical impedance analysis, compared between the metabolic syndrome group and the control group. Reported as a percentage of total body mass.
Measured: At the single study visit (Day 1)
Serum brain-derived neurotrophic factor (BDNF) concentration
Fasting serum BDNF concentration measured by enzyme-linked immunosorbent assay, compared between groups and correlated with metabolic syndrome components. Reported in ng/mL.
Measured: At the single study visit (Day 1)
Serum cortisol concentration
Fasting serum cortisol concentration measured by immunoassay, compared between groups and correlated with perceived stress and sleep quality scores. Reported in micrograms/dL.
Measured: At the single study visit (Day 1)
Quantitative Insulin Sensitivity Check Index (QUICKI)
QUICKI calculated from fasting glucose and fasting insulin as 1 / (log fasting insulin in microU/mL + log fasting glucose in mg/dL), compared between the metabolic syndrome group and the control group. Reported as an index score (unitless). Higher values indicate greater insulin sensitivity.
Measured: At the single study visit (Day 1)
Metabolic Score for Insulin Resistance (METS-IR)
METS-IR calculated from fasting glucose, fasting triglycerides, body mass index and HDL cholesterol, compared between the metabolic syndrome group and the control group. Reported as an index score (unitless). Higher values indicate greater insulin resistance.
Measured: At the single study visit (Day 1)
Triglyceride-Glucose Index (TyG)
TyG index calculated as the natural logarithm of (fasting triglycerides in mg/dL x fasting glucose in mg/dL) / 2, compared between the metabolic syndrome group and the control group. Reported as an index score (unitless). Higher values indicate greater insulin resistance.
Measured: At the single study visit (Day 1)
Castelli Risk Index II
Ratio of LDL cholesterol to HDL cholesterol, calculated from the fasting lipid profile and compared between the metabolic syndrome group and the control group. Reported as a ratio (unitless). Higher values indicate greater atherogenic risk.
Measured: At the single study visit (Day 1)
Atherogenic Index of Plasma (AIP)
Base-10 logarithm of the ratio of fasting triglycerides to HDL cholesterol, both expressed in mmol/L, compared between the metabolic syndrome group and the control group. Reported as a log-transformed ratio (unitless). Higher values indicate greater atherogenic risk.
Measured: At the single study visit (Day 1)
Fat-free mass
Fat-free mass (FFM) measured by bioelectrical impedance analysis, compared between the metabolic syndrome group and the control group. Reported in kilograms.
Measured: At the single study visit (Day 1)
Body Mass Index (BMI)
Body mass index calculated as body mass in kilograms divided by the square of body height in metres, compared between the metabolic syndrome group and the control group. Reported in kg/m^2.
Measured: At the single study visit (Day 1)
Waist-to-Hip Ratio (WHR)
Ratio of waist circumference to hip circumference, both measured in centimetres with an anthropometric tape, compared between the metabolic syndrome group and the control group. Reported as a ratio (unitless).
Measured: At the single study visit (Day 1)
Waist-to-Height Ratio (WHtR)
Ratio of waist circumference to body height, both measured in centimetres, compared between the metabolic syndrome group and the control group. Reported as a ratio (unitless).
Measured: At the single study visit (Day 1)
A Body Shape Index (ABSI)
ABSI calculated from waist circumference, body mass index and body height according to Krakauer and Krakauer, compared between the metabolic syndrome group and the control group. Reported as an index score. Higher values indicate greater central adiposity relative to body size.
Measured: At the single study visit (Day 1)
Hip Index (HI)
Hip Index calculated from hip circumference adjusted for body height and body mass, compared between the metabolic syndrome group and the control group. Reported as an index score.
Measured: At the single study visit (Day 1)
Body Adiposity Index (BAI)
BAI calculated from hip circumference and body height, compared between the metabolic syndrome group and the control group. Reported as estimated body fat expressed as a percentage of total body mass.
Measured: At the single study visit (Day 1)
Visceral Adiposity Index (VAI)
VAI calculated from waist circumference, body mass index, fasting triglycerides and HDL cholesterol using the sex-specific formula for women, compared between the metabolic syndrome group and the control group. Reported as an index score (unitless).
Measured: At the single study visit (Day 1)
Lipid Accumulation Product (LAP)
LAP calculated for women as (waist circumference in cm minus 58) multiplied by fasting triglycerides in mmol/L, compared between the metabolic syndrome group and the control group. Reported in cm x mmol/L.
Measured: At the single study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences in Nowy Targ
- Sponsor type
- University, hospital or other
- Collaborators
- University of Physical Education in Krakow, Poland, Maj Institute of Pharmacology, Polish Academy of Sciences (CEPHARES), Poland
- Responsible party
- Principal investigator, Małgorzata Kantorowicz, University of Applied Sciences in Nowy Targ
- Investigators
- Małgorzata Kantorowicz, Ph. D., Principal investigator, University of Applied Sciences in Nowy Targ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917364
- Sponsor's protocol ID
- SKN/SP/659046/2026
- Other IDs
- SKN/SP/659046/2026
- Acronym
- ASPRO-MetS
- Status last verified
- Nov 2026
- First submitted
- 16 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Data are collected under informed consent that specifies use for scientific purposes following anonymization, and the consent does not cover open data sharing. Anonymized aggregate results will be published in a peer-reviewed scientific journal. Requests for anonymized data may be directed to the principal investigator and will be considered subject to approval by the sponsor institution and the bioethics committee.
Publications
Krakauer NY, Krakauer JC. A new body shape index predicts mortality hazard independently of body mass index. PLoS One. 2012;7(7):e39504. doi: 10.1371/journal.pone.0039504. Epub 2012 Jul 18.
PubMed 22815707Bello-Chavolla OY, Almeda-Valdes P, Gomez-Velasco D, Viveros-Ruiz T, Cruz-Bautista I, Romo-Romo A, Sanchez-Lazaro D, Meza-Oviedo D, Vargas-Vazquez A, Campos OA, Sevilla-Gonzalez MDR, Martagon AJ, Hernandez LM, Mehta R, Caballeros-Barragan CR, Aguilar-Salinas CA. METS-IR, a novel score to evaluate insulin sensitivity, is predictive of visceral adiposity and incident type 2 diabetes. Eur J Endocrinol. 2018 May;178(5):533-544. doi: 10.1530/EJE-17-0883. Epub 2018 Mar 13.
PubMed 29535168Li M, Zhang J. Circulating MicroRNAs: Potential and Emerging Biomarkers for Diagnosis of Cardiovascular and Cerebrovascular Diseases. Biomed Res Int. 2015;2015:730535. doi: 10.1155/2015/730535. Epub 2015 May 28.
PubMed 26180810Wiecek M, Szymura J, Sproull J, Szygula Z. Whole-Body Cryotherapy Is an Effective Method of Reducing Abdominal Obesity in Menopausal Women with Metabolic Syndrome. J Clin Med. 2020 Aug 30;9(9):2797. doi: 10.3390/jcm9092797.
PubMed 32872598Wiecek M, Szymura J, Kusmierczyk J, Lipowska M, Szygula Z. Whole-Body Cryotherapy Improves Asprosin Secretion and Insulin Sensitivity in Postmenopausal Women-Perspectives in the Management of Type 2 Diabetes. Biomolecules. 2023 Oct 31;13(11):1602. doi: 10.3390/biom13111602.
PubMed 38002284Wiecek M, Szymura J, Maciejczyk M, Kantorowicz M, Szygula Z. Acute Anaerobic Exercise Affects the Secretion of Asprosin, Irisin, and Other Cytokines - A Comparison Between Sexes. Front Physiol. 2018 Dec 10;9:1782. doi: 10.3389/fphys.2018.01782. eCollection 2018.
PubMed 30618797Kusmierczyk J, Wiecek M, Bawelski M, Szygula Z, Rafa-Zablocka K, Kantorowicz M, Szymura J. Pre-exercise cryotherapy reduces myoglobin and creatine kinase levels after eccentric muscle stress in young women. Front Physiol. 2024 Jun 19;15:1413949. doi: 10.3389/fphys.2024.1413949. eCollection 2024.
PubMed 38962071Wiecek M, Mardyla M, Szymura J, Kantorowicz M, Kusmierczyk J, Maciejczyk M, Szygula Z. Maximal Intensity Exercise Induces Adipokine Secretion and Disrupts Prooxidant-Antioxidant Balance in Young Men with Different Body Composition. Int J Mol Sci. 2025 Jan 3;26(1):350. doi: 10.3390/ijms26010350.
PubMed 39796204Wiecek M, Kusmierczyk J, Szymura J, Kreiner G, Szygula Z. Whole-Body Cryotherapy Alters Circulating MicroRNA Profile in Postmenopausal Women. J Clin Med. 2023 Aug 12;12(16):5265. doi: 10.3390/jcm12165265.
PubMed 37629307Kantorowicz M, Szymura J, Szygula Z, Kusmierczyk J, Maciejczyk M, Wiecek M. Nordic Walking at Maximal Fat Oxidation Intensity Decreases Circulating Asprosin and Visceral Obesity in Women With Metabolic Disorders. Front Physiol. 2021 Sep 3;12:726783. doi: 10.3389/fphys.2021.726783. eCollection 2021.
PubMed 34539448Wen D, Qiao P, Wang L. Circulating microRNA-223 as a potential biomarker for obesity. Obes Res Clin Pract. 2015 Jul-Aug;9(4):398-404. doi: 10.1016/j.orcp.2015.01.006. Epub 2015 Apr 2.
PubMed 25842981Roos J, Enlund E, Funcke JB, Tews D, Holzmann K, Debatin KM, Wabitsch M, Fischer-Posovszky P. miR-146a-mediated suppression of the inflammatory response in human adipocytes. Sci Rep. 2016 Dec 6;6:38339. doi: 10.1038/srep38339.
PubMed 27922090Darabi F, Aghaei M, Movahedian A, Elahifar A, Pourmoghadas A, Sarrafzadegan N. Association of serum microRNA-21 levels with Visfatin, inflammation, and acute coronary syndromes. Heart Vessels. 2017 May;32(5):549-557. doi: 10.1007/s00380-016-0913-z. Epub 2016 Oct 26.
PubMed 27785570Deiuliis JA. MicroRNAs as regulators of metabolic disease: pathophysiologic significance and emerging role as biomarkers and therapeutics. Int J Obes (Lond). 2016 Jan;40(1):88-101. doi: 10.1038/ijo.2015.170. Epub 2015 Aug 27.
PubMed 26311337Karolina DS, Tavintharan S, Armugam A, Sepramaniam S, Pek SL, Wong MT, Lim SC, Sum CF, Jeyaseelan K. Circulating miRNA profiles in patients with metabolic syndrome. J Clin Endocrinol Metab. 2012 Dec;97(12):E2271-6. doi: 10.1210/jc.2012-1996. Epub 2012 Oct 2.
PubMed 23032062
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum Asprosin Concentration and Expression of Selected miRNAs With Risk Factors and Components of Metabolic Syndrome in Young Women: Diagnostic Perspectives
- ClinicalTrials.gov ID
- NCT07917364
- Acronym / sponsor ID
- ASPRO-MetS / SKN/SP/659046/2026
- Keywords
- Asprosin, microRNA, miRNA, Biomarkers, Young Women, Insulin Resistance, Cardiometabolic Risk, BDNF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Applied Sciences in Nowy TargUniversity, hospital or other
- Collaborators
- University of Physical Education in Krakow, Poland, Maj Institute of Pharmacology, Polish Academy of Sciences (CEPHARES), Poland
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Nov 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.
Metabolic syndrome is a major risk factor for cardiovascular disease and type 2 diabetes, and its prevalence in young adults is increasing. Early identification of individuals at risk may improve prevention strategies. This observational, cross-sectional case-control study investigates the relationship between serum asprosin concentration, the expression of six selected circulating microRNAs, and the components and risk factors of metabolic syndrome in young women aged 18 to 35 years. Two equally sized groups will be compared: women meeting NCEP ATP III criteria for metabolic syndrome and healthy age-matched controls. Participants attend a single study visit during which fasting blood samples, anthropometric and body composition measurements, blood pressure, and validated questionnaires assessing physical activity, diet, sleep quality, perceived stress, and quality of life are collected. The study aims to determine whether asprosin and the selected microRNA profile have diagnostic value as biomarkers of metabolic syndrome in this population.
Detailed description
Background. Metabolic syndrome is a complex disorder characterized by the coexistence of abdominal obesity, hypertension, dyslipidemia, and impaired glucose metabolism, resulting in an increased risk of cardiovascular disease and type 2 diabetes mellitus. Although established diagnostic criteria exist, there is an ongoing need for novel biomarkers that may improve early detection and clarify the pathophysiological mechanisms involved, particularly in young adults, in whom the condition remains under-investigated.
Asprosin is a fasting-induced adipokine implicated in glucose metabolism, insulin resistance, and obesity. Circulating microRNAs are considered promising molecular biomarkers involved in metabolic regulation and inflammatory pathways. Brain-derived neurotrophic factor (BDNF) and cortisol are additional candidate mediators linking metabolic, psychological, and sleep-related factors.
Objectives. The primary objective is to determine whether serum asprosin concentration and the expression of six selected circulating microRNAs (miR-15a-5p, miR-197-3p, miR-23a-3p, miR-21-5p, miR-146a-5p, miR-223-3p) differ between young women with metabolic syndrome and healthy age-matched women. Secondary objectives are to compare the prevalence of individual metabolic syndrome components, body composition, anthropometric, insulin resistance and atherogenic indices, physical activity, diet, sleep quality, perceived stress, and health-related quality of life between the groups, and to assess correlations between asprosin, the microRNA profile, and these variables.
Design and participants. A total of 110 women aged 18 to 35 years will be enrolled into two equally sized groups: women with metabolic syndrome without other comorbidities requiring continuous pharmacotherapy (MetS, n=55) and healthy women (CON, n=55). Sample size was calculated using G*Power 3.1.9.7; assuming a two-tailed independent-samples comparison, alpha = 0.05, effect size d = 0.5, and power = 0.80, the minimum required sample is 51 participants per group. Recruitment is continuous and conducted among young women in the Podhale region and the Malopolska Province, primarily in the academic community.
Procedures. Eligibility is screened via an online form. Eligible participants attend a single study visit of approximately 90 minutes at the Institute of Medicine of the University of Applied Sciences in Nowy Targ. After written informed consent, the following are performed: fasting venous blood collection (18 mL, antecubital vein, vacuum system, by qualified medical personnel); blood pressure measurement; anthropometric measurements (body height, body mass, waist, abdominal and hip circumference) and body composition assessment by bioelectrical impedance analysis (BIA); and completion of validated questionnaires - International Physical Activity Questionnaire (IPAQ) and 7-day Physical Activity Recall (7day-PAR), Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10), Food Frequency Questionnaire (FFQ) or KomPAN together with the Fitatu dietary application, and the Short Form-36 Health Survey (SF-36).
Laboratory analyses performed immediately in a certified external laboratory: complete blood count, fasting glucose, glycated hemoglobin, insulin, and lipid profile. Plasma is separated by centrifugation at 2500 RCF for 15 minutes, aliquoted, and stored at -80 degrees C until batch analysis of asprosin, BDNF, cortisol, and the microRNA panel.
Metabolic syndrome diagnosis. Made by a physician according to NCEP ATP III criteria for women, requiring at least three of five components: triglycerides greater than 150 mg/dL; HDL cholesterol below 50 mg/dL; blood pressure greater than 130/85 mmHg or antihypertensive treatment; fasting glucose greater than 100 mg/dL or previously diagnosed diabetes; waist circumference greater than 88 cm.
Derived indices. BMI, WHR, WHtR, A Body Shape Index (ABSI), Hip Index (HI), Body Adiposity Index (BAI), Visceral Adiposity Index (VAI), Lipid Accumulation Product (LAP), HOMA-IR, QUICKI, METS-IR, triglyceride-glucose index (TyG), Castelli Risk Index I and II (CRI-I, CRI-II), and Atherogenic Index of Plasma (AIP).
Statistical analysis. Distribution of variables will be assessed using the Shapiro-Wilk test. Between-group comparisons will use the independent-samples t-test or the Mann-Whitney U test as appropriate. Correlations will be assessed using Pearson or Spearman coefficients. Statistical significance will be set at p less than 0.05.
All participants will receive their individual results. Data will be anonymized before analysis and scientific use.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic Syndrome Group (MetS) | – | Diagnostic Test: Biomarker panel (asprosin, microRNA, BDNF, cortisol), Other: Clinical and questionnaire assessmentWomen aged 18-35 years meeting NCEP ATP III criteria for metabolic syndrome (at least three of five components: triglycerides greater than 150 mg/dL; HDL cholesterol below 50 mg/dL; blood pressure greater than 130/85 mmHg or antihypertensive treatment; fasting glucose greater than 100 mg/dL or previously diagnosed diabetes; waist circumference greater than 88 cm), with no other comorbidity requiring continuous pharmacotherapy. Target n=55. |
| Control Group (CON) | – | Diagnostic Test: Biomarker panel (asprosin, microRNA, BDNF, cortisol), Other: Clinical and questionnaire assessmentHealthy women aged 18-35 years not meeting NCEP ATP III criteria for metabolic syndrome, matched for age, not receiving continuous pharmacotherapy. Target n=55. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 18 to 35 years recruited from the general and academic population of the Podhale region and the Malopolska Province, Poland, through university websites, e-mail, social media, local press, printed posters and leaflets, and information meetings. Eligibility is screened using an online questionnaire. Enrolled participants form two equally sized groups: women diagnosed with metabolic syndrome according to NCEP ATP III criteria and healthy women of comparable age.
Key inclusion criteria (8 listed)
- Female sex
- Age 18 to 35 years
- Regular menstrual cycle
- Not engaged in competitive sports training in any discipline
- Non-smoker
Key exclusion criteria (8 listed)
- Age outside the range of 18 to 35 years
- Irregular menstrual cycle
- Pregnancy or breastfeeding
- Continuous pharmacotherapy for indications other than diabetes and/or hypertension, including any form of hormonal contraception (oral, transdermal, vaginal, implant, injectable or intrauterine)
- Competitive sports training in any discipline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker panel (asprosin, microRNA, BDNF, cortisol)Fasting venous blood collection for measurement of serum asprosin, BDNF and cortisol concentrations, and expression of six circulating microRNAs (miR-15a-5p, miR-197-3p, miR-23a-3p, miR-21-5p, miR-146a-5p, miR-223-3p), in addition to complete blood count, glucose, glycated hemoglobin, insulin, and lipid profile. | Diagnostic test | Control Group (CON), Metabolic Syndrome Group (MetS) |
| Clinical and questionnaire assessmentBlood pressure measurement, anthropometric measurements and bioelectrical impedance body composition analysis, and completion of validated questionnaires (IPAQ, 7day-PAR, PSQI, PSS-10, FFQ/KomPAN with the Fitatu application, SF-36). | Other | Control Group (CON), Metabolic Syndrome Group (MetS) |
Primary outcome
Serum asprosin concentration
Time frame: At the single study visit (Day 1)
Fasting serum asprosin concentration measured by enzyme-linked immunosorbent assay, compared between women with metabolic syndrome and healthy controls. Reported in ng/mL.
Expression of selected circulating microRNAs
Time frame: At the single study visit (Day 1)
Relative expression of six circulating microRNAs (miR-15a-5p, miR-197-3p, miR-23a-3p, miR-21-5p, miR-146a-5p, miR-223-3p) quantified in plasma by reverse-transcription quantitative PCR. Expression is normalized using ath-miR159a as an exogenous spike-in control and hsa-miR-186-5p as a reference. All six analytes are measured by the same method and reported in the same unit of measure, relative fold change, with results reported separately for each microRNA.
20 secondary outcomes
Prevalence of individual metabolic syndrome components
Time frame: At the single study visit (Day 1)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: At the single study visit (Day 1)
Castelli Risk Index I
Time frame: At the single study visit (Day 1)
Body fat percentage
Time frame: At the single study visit (Day 1)
Serum brain-derived neurotrophic factor (BDNF) concentration
Time frame: At the single study visit (Day 1)
Serum cortisol concentration
Time frame: At the single study visit (Day 1)
Quantitative Insulin Sensitivity Check Index (QUICKI)
Time frame: At the single study visit (Day 1)
Metabolic Score for Insulin Resistance (METS-IR)
Time frame: At the single study visit (Day 1)
Triglyceride-Glucose Index (TyG)
Time frame: At the single study visit (Day 1)
Castelli Risk Index II
Time frame: At the single study visit (Day 1)
Atherogenic Index of Plasma (AIP)
Time frame: At the single study visit (Day 1)
Fat-free mass
Time frame: At the single study visit (Day 1)
Body Mass Index (BMI)
Time frame: At the single study visit (Day 1)
Waist-to-Hip Ratio (WHR)
Time frame: At the single study visit (Day 1)
Waist-to-Height Ratio (WHtR)
Time frame: At the single study visit (Day 1)
A Body Shape Index (ABSI)
Time frame: At the single study visit (Day 1)
Hip Index (HI)
Time frame: At the single study visit (Day 1)
Body Adiposity Index (BAI)
Time frame: At the single study visit (Day 1)
Visceral Adiposity Index (VAI)
Time frame: At the single study visit (Day 1)
Lipid Accumulation Product (LAP)
Time frame: At the single study visit (Day 1)
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 4 Nov 2026.
- Background: PubMed 22815707Krakauer NY, Krakauer JC. A new body shape index predicts mortality hazard independently of body mass index. PLoS One. 2012;7(7):e39504. doi: 10.1371/journal.pone.0039504. Epub 2012 Jul 18.
- Background: PubMed 29535168Bello-Chavolla OY, Almeda-Valdes P, Gomez-Velasco D, Viveros-Ruiz T, Cruz-Bautista I, Romo-Romo A, Sanchez-Lazaro D, Meza-Oviedo D, Vargas-Vazquez A, Campos OA, Sevilla-Gonzalez MDR, Martagon AJ, Hernandez LM, Mehta R, Caballeros-Barragan CR, Aguilar-Salinas CA. METS-IR, a novel score to evaluate insulin sensitivity, is predictive of visceral adiposity and incident type 2 diabetes. Eur J Endocrinol. 2018 May;178(5):533-544. doi: 10.1530/EJE-17-0883. Epub 2018 Mar 13.
- Background: PubMed 26180810Li M, Zhang J. Circulating MicroRNAs: Potential and Emerging Biomarkers for Diagnosis of Cardiovascular and Cerebrovascular Diseases. Biomed Res Int. 2015;2015:730535. doi: 10.1155/2015/730535. Epub 2015 May 28.
- Background: PubMed 32872598Wiecek M, Szymura J, Sproull J, Szygula Z. Whole-Body Cryotherapy Is an Effective Method of Reducing Abdominal Obesity in Menopausal Women with Metabolic Syndrome. J Clin Med. 2020 Aug 30;9(9):2797. doi: 10.3390/jcm9092797.
- Background: PubMed 38002284Wiecek M, Szymura J, Kusmierczyk J, Lipowska M, Szygula Z. Whole-Body Cryotherapy Improves Asprosin Secretion and Insulin Sensitivity in Postmenopausal Women-Perspectives in the Management of Type 2 Diabetes. Biomolecules. 2023 Oct 31;13(11):1602. doi: 10.3390/biom13111602.
- Background: PubMed 30618797Wiecek M, Szymura J, Maciejczyk M, Kantorowicz M, Szygula Z. Acute Anaerobic Exercise Affects the Secretion of Asprosin, Irisin, and Other Cytokines - A Comparison Between Sexes. Front Physiol. 2018 Dec 10;9:1782. doi: 10.3389/fphys.2018.01782. eCollection 2018.
- Background: PubMed 38962071Kusmierczyk J, Wiecek M, Bawelski M, Szygula Z, Rafa-Zablocka K, Kantorowicz M, Szymura J. Pre-exercise cryotherapy reduces myoglobin and creatine kinase levels after eccentric muscle stress in young women. Front Physiol. 2024 Jun 19;15:1413949. doi: 10.3389/fphys.2024.1413949. eCollection 2024.
- Background: PubMed 39796204Wiecek M, Mardyla M, Szymura J, Kantorowicz M, Kusmierczyk J, Maciejczyk M, Szygula Z. Maximal Intensity Exercise Induces Adipokine Secretion and Disrupts Prooxidant-Antioxidant Balance in Young Men with Different Body Composition. Int J Mol Sci. 2025 Jan 3;26(1):350. doi: 10.3390/ijms26010350.
- Background: PubMed 37629307Wiecek M, Kusmierczyk J, Szymura J, Kreiner G, Szygula Z. Whole-Body Cryotherapy Alters Circulating MicroRNA Profile in Postmenopausal Women. J Clin Med. 2023 Aug 12;12(16):5265. doi: 10.3390/jcm12165265.
- Background: PubMed 34539448Kantorowicz M, Szymura J, Szygula Z, Kusmierczyk J, Maciejczyk M, Wiecek M. Nordic Walking at Maximal Fat Oxidation Intensity Decreases Circulating Asprosin and Visceral Obesity in Women With Metabolic Disorders. Front Physiol. 2021 Sep 3;12:726783. doi: 10.3389/fphys.2021.726783. eCollection 2021.
- Background: PubMed 25842981Wen D, Qiao P, Wang L. Circulating microRNA-223 as a potential biomarker for obesity. Obes Res Clin Pract. 2015 Jul-Aug;9(4):398-404. doi: 10.1016/j.orcp.2015.01.006. Epub 2015 Apr 2.
- Background: PubMed 27922090Roos J, Enlund E, Funcke JB, Tews D, Holzmann K, Debatin KM, Wabitsch M, Fischer-Posovszky P. miR-146a-mediated suppression of the inflammatory response in human adipocytes. Sci Rep. 2016 Dec 6;6:38339. doi: 10.1038/srep38339.
- Sponsor institution websiteLink provided by the sponsor.
- International Diabetes Federation Diabetes Atlas - global diabetes prevalence data cited in the study rationaleLink provided by the sponsor.
- TarBase v9.0 - database of experimentally supported miRNA-gene interactions used for target selectionLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Data are collected under informed consent that specifies use for scientific purposes following anonymization, and the consent does not cover open data sharing. Anonymized aggregate results will be published in a peer-reviewed scientific journal. Requests for anonymized data may be directed to the principal investigator and will be considered subject to approval by the sponsor institution and the bioethics committee.
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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.
Małgorzata Kantorowicz, Ph. D. principal investigator
University of Applied Sciences in Nowy Targ
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 Metabolic Syndrome and Insulin Resistance, run by University of Applied Sciences in Nowy Targ 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Nov 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 Małgorzata Kantorowicz, Ph.D. (+48 662 251 012, sknmedicus@ans-nt.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum asprosin concentration (time frame: At the single study visit (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07917364, which also lists 29 linked publications.
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 4 Nov 2026.