Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome

The study is planned to be conducted on 40 adults with metabolic syndrome. As a control, it is planned to recruit 40 adults without metabolic syndrome. From all participants fasting venous blood samples, urine samples and hair samples will be collected. Next, serum progranulin and serum FAM19A5 protein concentrations will be determined in both groups. Also, serum concentration of leptin, vascular endothelial growth factor (VEGF), insulin, neopterin, adropin and selected cytokines, adipokines, myokines and chemokines, total cholesterol, low-density lipoproteins, high-density lipoproteins, triglycerides and glucose will be determined. Serum, hair and urine mineral content will be determined. In whole blood genetic analyses will be performed in order to detect and examine progranulin and FAM19A5 genes, and genes associated with the development of metabolic syndrome and genes associated with the body's mineral metabolism. Also, body composition analysis, blood pressure measurement, pulse measurement, blood oxygen saturation measurement and nutritional interview will be performed.

• Blood sample collection (Diagnostic test): Fasting blood sample will be collected from forearm vein. In the sample the concentration of: progranulin and serum FAM19A5 protein, leptin, VEGF, insulin, neopterin, adropin and selected cytokines, adipokines, myokines and chemokines, total cholesterol, low-density lipoproteins, high-density lipoproteins, triglycerides and glucose will be determined. Whole blood sample will be secured to isolate genetic material, detect and examine progranulin and FAM19A5 genes, and genes associated with the development of metabolic syndrome and with the body's mineral management. Serum mineral analysis will be performed.
• Hair sample collection (Diagnostic test): Hair sample collection will be performed. Hair mineral analysis will be performed.
• Urine sample collection (Diagnostic test): Urine sample collection will be performed. Urine mineral analysis will be performed.
• Body composition analysis (Diagnostic test): Body composition analysis with the use of electric bioimpedance will be performed.
• Questionnaires (Diagnostic test): Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.
• Blood pressure, pulse and blood oxygen saturation measurement (Diagnostic test): Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.

Primary outcomes

• Progranulin [Measured at baseline]: Concentration of progranulin in serum
• FAM19A5 Protein [Measured at baseline]: Concentration of FAM19A5 protein in serum

Secondary outcomes

• Progranulin genes [Measured at baseline]: Detection and testing of progranulin genes
• FAM19A5 protein genes [Measured at baseline]: Detection and testing of FAM19A5 protein genes
• Leptin [Measured at baseline]: Concentration of leptin in serum
• Vascular endothelial growth factor (VGEF) [Measured at baseline]: Concentration of VGEF in serum
• Insulin [Measured at baseline]: Concentration of insulin in serum
• Neopterin [Measured at baseline]: Concentration of neopterin in serum
• Adropin [Measured at baseline]: Concentration of adropin in serum
• Iron level in hair [Measured at baseline]: The content of iron will be determined in hair (atomic absorption spectrometry)
• Zinc level in hair [Measured at baseline]: The content of zinc will be determined in hair (atomic absorption spectrometry)
• Copper level in hair [Measured at baseline]: The content of copper will be determined in hair (atomic absorption spectrometry)
• Iron level in serum [Measured at baseline]: The content of iron will be determined in serum (atomic absorption spectrometry)
• Zinc level in serum [Measured at baseline]: The content of zinc will be determined in serum (atomic absorption spectrometry)
• Copper level in serum [Measured at baseline]: The content of copper will be determined in serum (atomic absorption spectrometry)
• Iron level in urine [Measured at baseline]: The content of iron will be determined in urine (atomic absorption spectrometry)
• Zinc level in urine [Measured at baseline]: The content of zinc will be determined in urine (atomic absorption spectrometry)
• Copper level in urine [Measured at baseline]: The content of copper will be determined in urine (atomic absorption spectrometry)
• Body mass (BM) [Measured at baseline]: Body mass
• Waist circumference (WC) [Measured at baseline]: Waist circumference
• Hip circumference [Measured at baseline]: Hip circumference
• Neck circumference [Measured at baseline]: Neck circumference
• Body fat content [Measured at baseline]: Body fat content in bioimpedance
• Muscle mass content [Measured at baseline]: Muscle mass content in bioimpedance
• Total water content [Measured at baseline]: Total water content in bioimpedance
• Systolic blood pressure [Measured at baseline]: Measurement of systolic blood pressure
• Diastolic blood pressure [Measured at baseline]: Measurement of diastolic blood pressure
• Pulse [Measured at baseline]: Measurement of pulse
• Blood oxygen level [Measured at baseline]: Measurement of blood oxygen level- measured non-invasively with the use of oximeter
• Total cholesterol (TCH) [Measured at baseline]: Blood concentration of total cholesterol
• Low density lipoprotein (LDL) [Measured at baseline]: Blood concentration of low density lipoprotein (LDL)
• High density lipoprotein (HDL) [Measured at baseline]: Blood concentration of high density lipoprotein (HDL)
• Triglycerides [Measured at baseline]: Blood concentration of triglycerides
• Glucose [Measured at baseline]: Blood concentration of glucose

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

Inclusion Criteria:

* written and informed consent of the participant to participate in the study;
* age 18-99;
* meeting at least three of the following five metabolic syndrome criteria:

  * waist circumference ≥80 cm in women and ≥94 cm in men;
  * serum triglycerides> 150 mg / dl (1.7 mmol / l) or treatment of hypertriglyceridemia;
  * HDL serum concentration <50 mg / dl (1.3 mmol / l) - in women and <40 mg / dl (1.0 mmol / l) - in men or treatment of this lipid disorder;
  * systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg, or treatment of previously diagnosed hypertension;
  * fasting plasma glucose ≥100 mg / dl (5.6 mmol / l) or pharmacological treatment of type 2 diabetes.

Exclusion Criteria:

* secondary form obesity,
* substitution of progranulin or / and FAM19A5 protein,
* weight reduction above 5% of baseline body weight in the last 3 months preceding recruitment,
* liposuction and / or other fat reduction treatments,
* pacemaker, cardioverter / defibrillator,
* condition after stroke,
* Alzheimer's disease,
* fronto-temporal dementia,
* occurrence of other neurodegenerative diseases,
* occurrence of significant neurological disorders,
* occurrence of inflammatory autoimmune diseases,
* lysosomal storage diseases,
* clinically significant abnormal liver, kidney or thyroid function;
* acute or clinically significant inflammatory process in the respiratory, digestive, genitourinary tracts,
* connective tissue diseases or arthritis;
* active cancer,
* addiction to alcohol or drugs;
* pregnancy or childbirth during recruitment or 3 months before recruitment;
* current lactation or lactation within 3 months before recruitment;
* and / or any other condition which, according to researchers, would cause that participation would not be in the patient's best interest or could limit the credibility of the study

• Damian Skrypnik, MD; PhD, Study chair, Poznan University of Medical Sciences