Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome

Study Overview
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Brief Summary
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The main objective of the study is to assess the serum levels of progranulin and FAM19A5 protein in adults with metabolic syndrome.

Detailed Description
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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.

Official Title
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Assessment of Progranulin and Chemokine-like Protein TAFA-5 (FAM19A5) Blood Levels in Adults With Metabolic Syndrome

Conditions
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Obesity, Hypertension, Nutrition Disorders, Dyslipidemias, Glucose Intolerance, Glucose Metabolism Disorders, Overweight and Obesity, Metabolic Syndrome

Intervention / Treatment
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* Diagnostic Test: Blood sample collection
* Diagnostic Test: Hair sample collection
* Diagnostic Test: Urine sample collection
* Diagnostic Test: Body composition analysis
* Diagnostic Test: Questionnaires
* Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A - study group - patients with metabolic syndrome<br>Patients with metabolic syndrome will be included. Procedures: blood sample collection hair sample collection urine sample collection body composition analysis questionnaires blood pressure, pulse and blood oxygen saturation measurement | Diagnostic Test: Blood sample collection<br>* 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.<br>Diagnostic Test: Hair sample collection<br>* Hair sample collection will be performed. Hair mineral analysis will be performed.<br>Diagnostic Test: Urine sample collection<br>* Urine sample collection will be performed. Urine mineral analysis will be performed.<br>Diagnostic Test: Body composition analysis<br>* Body composition analysis with the use of electric bioimpedance will be performed.<br>Diagnostic Test: Questionnaires<br>* Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.<br>Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurement<br>* Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.<br>|
| Group B - control group - patients without metabolic syndrome<br>Patients without metabolic syndrome will be included. blood sample collection hair sample collection urine sample collection body composition analysis questionnaires blood pressure, pulse and blood oxygen saturation measurement | Diagnostic Test: Blood sample collection<br>* 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.<br>Diagnostic Test: Hair sample collection<br>* Hair sample collection will be performed. Hair mineral analysis will be performed.<br>Diagnostic Test: Urine sample collection<br>* Urine sample collection will be performed. Urine mineral analysis will be performed.<br>Diagnostic Test: Body composition analysis<br>* Body composition analysis with the use of electric bioimpedance will be performed.<br>Diagnostic Test: Questionnaires<br>* Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.<br>Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurement<br>* Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progranulin | Concentration of progranulin in serum | Measured at baseline | 
| FAM19A5 Protein | Concentration of FAM19A5 protein in serum | Measured at baseline | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Hypertension, Dyslipidemia, Progranulin, FAM19A5, Adipokines, Metabolic syndrome