An observational study in Metabolic Syndrome, Insulin Resistance and Obesity, Abdominal, sponsored by University of Applied Sciences in Nowy Targ. Recruiting at 1 site in Poland. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Applied Sciences in Nowy Targ · Observational
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.
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.
2,015 studies on the registry are indexed under Metabolic Syndrome; 335 are open to participants now.
This study's planned enrollment of 110 is below the median of 200 across 471 observational studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →This is the only study on the registry with University of Applied Sciences in Nowy Targ as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: Biomarker panel (asprosin, microRNA, BDNF, cortisol) · Other: Clinical and questionnaire assessment
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.
Diagnostic Test: Biomarker panel (asprosin, microRNA, BDNF, cortisol) · Other: Clinical and questionnaire assessment
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.
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).
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.
Time frame: 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.
Time frame: At the single study visit (Day 1)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: At the single study visit (Day 1)
Physical activity level assessed by the International Physical Activity Questionnaire (IPAQ)
Habitual physical activity assessed using the International Physical Activity Questionnaire, compared between the metabolic syndrome group and the control group. Reported as total physical activity in MET-minutes per week. Higher values indicate a higher level of physical activity.
Time frame: At the single study visit (Day 1)
Sleep quality
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Global score range 0 to 21; higher scores indicate worse sleep quality, with a score above 5 indicating poor sleep quality.
Time frame: At the single study visit (Day 1)
Perceived stress level
Perceived stress assessed using the 10-item Perceived Stress Scale (PSS-10). Score range 0 to 40; higher scores indicate higher perceived stress.
Time frame: At the single study visit (Day 1)
Daily energy intake
Habitual daily energy intake assessed using a Food Frequency Questionnaire or the KomPAN questionnaire together with the Fitatu dietary application, compared between the metabolic syndrome group and the control group. Reported in kilocalories per day.
Time frame: At the single study visit (Day 1)
Health-related quality of life
Health-related quality of life assessed using the Short Form-36 Health Survey (SF-36). Domain and summary scores range 0 to 100; higher scores indicate better perceived health.
Time frame: At the single study visit (Day 1)
Waist circumference
Waist circumference measured with an anthropometric tape according to standard protocol, compared between the metabolic syndrome group and the control group. Reported in centimetres.
Time frame: At the single study visit (Day 1)
Abdominal circumference
Abdominal circumference measured with an anthropometric tape at the level of the umbilicus, compared between the metabolic syndrome group and the control group. Reported in centimetres.
Time frame: At the single study visit (Day 1)
Hip circumference
Hip circumference measured with an anthropometric tape at the level of the greatest gluteal protrusion, compared between the metabolic syndrome group and the control group. Reported in centimetres.
Time frame: At the single study visit (Day 1)
Body mass
Body mass measured on a calibrated scale integrated with the bioelectrical impedance analyser, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Target body mass
Target body mass calculated by the bioelectrical impedance analyser from measured body composition, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Fat mass
Mass of body fat (MBF) measured by bioelectrical impedance analysis, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Soft lean mass
Soft lean mass (SLM) measured by bioelectrical impedance analysis, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Skeletal muscle mass
Skeletal muscle mass (SMM) measured by bioelectrical impedance analysis, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Total body water
Total body water (TBW) measured by bioelectrical impedance analysis, compared between groups. Reported as a percentage of total body mass.
Time frame: At the single study visit (Day 1)
Extracellular water ratio
Ratio of extracellular water to total body water (ECW ratio) measured by bioelectrical impedance analysis, compared between groups. Reported as a ratio (unitless).
Time frame: At the single study visit (Day 1)
Body cell mass
Body cell mass (BCM) measured by bioelectrical impedance analysis, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Protein content
Total body protein content measured by bioelectrical impedance analysis, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Mineral content
Total body mineral content measured by bioelectrical impedance analysis, compared between groups. Reported in kilograms.
Time frame: At the single study visit (Day 1)
Physical activity energy expenditure assessed by the 7-day Physical Activity Recall (7day-PAR)
Physical activity energy expenditure over the preceding seven days assessed using the 7-day Physical Activity Recall interview, compared between the metabolic syndrome group and the control group. Reported as mean daily energy expenditure in kilocalories per day.
Time frame: At the single study visit (Day 1)
Macronutrient distribution of the diet
Contribution of protein, fat and carbohydrate to total daily energy intake, assessed using a Food Frequency Questionnaire or the KomPAN questionnaire together with the Fitatu dietary application, compared between the metabolic syndrome group and the control group. Reported as a percentage of total daily energy intake for each macronutrient.
Time frame: At the single study visit (Day 1)
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.