<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451616</url>
  </required_header>
  <id_info>
    <org_study_id>353/20</org_study_id>
    <nct_id>NCT04451616</nct_id>
  </id_info>
  <brief_title>Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome</brief_title>
  <acronym>PROG-FAM</acronym>
  <official_title>Assessment of Progranulin and Chemokine-like Protein TAFA-5 (FAM19A5) Blood Levels in Adults With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poznan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to assess the serum levels of progranulin and FAM19A5&#xD;
      protein in adults with metabolic syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is planned to be conducted on 40 adults with metabolic syndrome. As a control, it&#xD;
      is planned to recruit 40 adults without metabolic syndrome. From all participants fasting&#xD;
      venous blood samples, urine samples and hair samples will be collected. Next, serum&#xD;
      progranulin and serum FAM19A5 protein concentrations will be determined in both groups. Also,&#xD;
      serum concentration of leptin, vascular endothelial growth factor (VEGF), insulin, neopterin,&#xD;
      adropin and selected cytokines, adipokines, myokines and chemokines, total cholesterol,&#xD;
      low-density lipoproteins, high-density lipoproteins, triglycerides and glucose will be&#xD;
      determined. Serum, hair and urine mineral content will be determined. In whole blood genetic&#xD;
      analyses will be performed in order to detect and examine progranulin and FAM19A5 genes, and&#xD;
      genes associated with the development of metabolic syndrome and genes associated with the&#xD;
      body's mineral metabolism. Also, body composition analysis, blood pressure measurement, pulse&#xD;
      measurement, blood oxygen saturation measurement and nutritional interview will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Progranulin</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Concentration of progranulin in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAM19A5 Protein</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Concentration of FAM19A5 protein in serum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progranulin genes</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Detection and testing of progranulin genes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAM19A5 protein genes</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Detection and testing of FAM19A5 protein genes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leptin</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Concentration of leptin in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular endothelial growth factor (VGEF)</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Concentration of VGEF in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Concentration of insulin in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neopterin</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Concentration of neopterin in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adropin</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Concentration of adropin in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron level in hair</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of iron will be determined in hair (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zinc level in hair</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of zinc will be determined in hair (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Copper level in hair</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of copper will be determined in hair (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron level in serum</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of iron will be determined in serum (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zinc level in serum</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of zinc will be determined in serum (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Copper level in serum</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of copper will be determined in serum (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron level in urine</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of iron will be determined in urine (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zinc level in urine</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of zinc will be determined in urine (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Copper level in urine</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>The content of copper will be determined in urine (atomic absorption spectrometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass (BM)</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Body mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference (WC)</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Hip circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck circumference</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Neck circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat content</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Body fat content in bioimpedance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle mass content</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Muscle mass content in bioimpedance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total water content</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Total water content in bioimpedance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Measurement of systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Measurement of diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Measurement of pulse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood oxygen level</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Measurement of blood oxygen level- measured non-invasively with the use of oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol (TCH)</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Blood concentration of total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low density lipoprotein (LDL)</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Blood concentration of low density lipoprotein (LDL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High density lipoprotein (HDL)</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Blood concentration of high density lipoprotein (HDL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Blood concentration of triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Blood concentration of glucose</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Nutrition Disorders</condition>
  <condition>Hypertension</condition>
  <condition>Dyslipidemias</condition>
  <condition>Glucose Intolerance</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <condition>Obesity</condition>
  <condition>Overweight and Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Group A - study group - patients with metabolic syndrome</arm_group_label>
    <description>Patients with metabolic syndrome will be included.&#xD;
Procedures:&#xD;
blood sample collection&#xD;
hair sample collection&#xD;
urine sample collection&#xD;
body composition analysis&#xD;
questionnaires&#xD;
blood pressure, pulse and blood oxygen saturation measurement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - control group - patients without metabolic syndrome</arm_group_label>
    <description>Patients without metabolic syndrome will be included.&#xD;
blood sample collection&#xD;
hair sample collection&#xD;
urine sample collection&#xD;
body composition analysis&#xD;
questionnaires&#xD;
blood pressure, pulse and blood oxygen saturation measurement</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sample collection</intervention_name>
    <description>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.</description>
    <arm_group_label>Group A - study group - patients with metabolic syndrome</arm_group_label>
    <arm_group_label>Group B - control group - patients without metabolic syndrome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hair sample collection</intervention_name>
    <description>Hair sample collection will be performed. Hair mineral analysis will be performed.</description>
    <arm_group_label>Group A - study group - patients with metabolic syndrome</arm_group_label>
    <arm_group_label>Group B - control group - patients without metabolic syndrome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urine sample collection</intervention_name>
    <description>Urine sample collection will be performed. Urine mineral analysis will be performed.</description>
    <arm_group_label>Group A - study group - patients with metabolic syndrome</arm_group_label>
    <arm_group_label>Group B - control group - patients without metabolic syndrome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Body composition analysis</intervention_name>
    <description>Body composition analysis with the use of electric bioimpedance will be performed.</description>
    <arm_group_label>Group A - study group - patients with metabolic syndrome</arm_group_label>
    <arm_group_label>Group B - control group - patients without metabolic syndrome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.</description>
    <arm_group_label>Group A - study group - patients with metabolic syndrome</arm_group_label>
    <arm_group_label>Group B - control group - patients without metabolic syndrome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood pressure, pulse and blood oxygen saturation measurement</intervention_name>
    <description>Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.</description>
    <arm_group_label>Group A - study group - patients with metabolic syndrome</arm_group_label>
    <arm_group_label>Group B - control group - patients without metabolic syndrome</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples of blood, hair and urine will be collected. From whole-blood samples of serum and&#xD;
      plasma will be determined. From whole-blood genetic material will be isolated. Samples of&#xD;
      serum, plasma, whole-blood, urine and serum will be signed with patient's unique code&#xD;
      preventing patient's data identification. Only study team will have access to samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        40 people (women and men) with metabolic syndrome (study group) and 40 people (women and&#xD;
        men) without metabolic syndrome (control group).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written and informed consent of the participant to participate in the study;&#xD;
&#xD;
          -  age 18-99;&#xD;
&#xD;
          -  meeting at least three of the following five metabolic syndrome criteria:&#xD;
&#xD;
               -  waist circumference ≥80 cm in women and ≥94 cm in men;&#xD;
&#xD;
               -  serum triglycerides&gt; 150 mg / dl (1.7 mmol / l) or treatment of&#xD;
                  hypertriglyceridemia;&#xD;
&#xD;
               -  HDL serum concentration &lt;50 mg / dl (1.3 mmol / l) - in women and &lt;40 mg / dl&#xD;
                  (1.0 mmol / l) - in men or treatment of this lipid disorder;&#xD;
&#xD;
               -  systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg, or&#xD;
                  treatment of previously diagnosed hypertension;&#xD;
&#xD;
               -  fasting plasma glucose ≥100 mg / dl (5.6 mmol / l) or pharmacological treatment&#xD;
                  of type 2 diabetes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary form obesity,&#xD;
&#xD;
          -  substitution of progranulin or / and FAM19A5 protein,&#xD;
&#xD;
          -  weight reduction above 5% of baseline body weight in the last 3 months preceding&#xD;
             recruitment,&#xD;
&#xD;
          -  liposuction and / or other fat reduction treatments,&#xD;
&#xD;
          -  pacemaker, cardioverter / defibrillator,&#xD;
&#xD;
          -  condition after stroke,&#xD;
&#xD;
          -  Alzheimer's disease,&#xD;
&#xD;
          -  fronto-temporal dementia,&#xD;
&#xD;
          -  occurrence of other neurodegenerative diseases,&#xD;
&#xD;
          -  occurrence of significant neurological disorders,&#xD;
&#xD;
          -  occurrence of inflammatory autoimmune diseases,&#xD;
&#xD;
          -  lysosomal storage diseases,&#xD;
&#xD;
          -  clinically significant abnormal liver, kidney or thyroid function;&#xD;
&#xD;
          -  acute or clinically significant inflammatory process in the respiratory, digestive,&#xD;
             genitourinary tracts,&#xD;
&#xD;
          -  connective tissue diseases or arthritis;&#xD;
&#xD;
          -  active cancer,&#xD;
&#xD;
          -  addiction to alcohol or drugs;&#xD;
&#xD;
          -  pregnancy or childbirth during recruitment or 3 months before recruitment;&#xD;
&#xD;
          -  current lactation or lactation within 3 months before recruitment;&#xD;
&#xD;
          -  and / or any other condition which, according to researchers, would cause that&#xD;
             participation would not be in the patient's best interest or could limit the&#xD;
             credibility of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damian Skrypnik, MD; PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Poznan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Damian Skrypnik, MD, PhD</last_name>
    <phone>+48 618549742</phone>
    <email>damian.skrypnik@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Agnieszka Wesołek, licentiate</last_name>
    <phone>+48 618549742</phone>
    <email>aa.wesolek@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences</name>
      <address>
        <city>Poznan</city>
        <state>Wielkopolska</state>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damian Skrypnik, MD, PhD</last_name>
      <phone>+48798394812</phone>
      <email>damian.skrypnik@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Paweł Bogdański, Prof.</last_name>
      <phone>+48502335001</phone>
      <email>pawelbogdanski73@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>Progranulin</keyword>
  <keyword>FAM19A5</keyword>
  <keyword>Adipokines</keyword>
  <keyword>Metabolic syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451616
org study id: 353/20
nct id: NCT04451616
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of the study is to assess the serum levels of progranulin and FAM19A5
      protein in adults with 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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Progranulin
time frame: Measured at baseline
description: Concentration of progranulin in serum
measure: FAM19A5 Protein
time frame: Measured at baseline
description: Concentration of FAM19A5 protein in serum
measure: Progranulin genes
time frame: Measured at baseline
description: Detection and testing of progranulin genes
measure: FAM19A5 protein genes
time frame: Measured at baseline
description: Detection and testing of FAM19A5 protein genes
measure: Leptin
time frame: Measured at baseline
description: Concentration of leptin in serum
measure: Vascular endothelial growth factor (VGEF)
time frame: Measured at baseline
description: Concentration of VGEF in serum
measure: Insulin
time frame: Measured at baseline
description: Concentration of insulin in serum
measure: Neopterin
time frame: Measured at baseline
description: Concentration of neopterin in serum
measure: Adropin
time frame: Measured at baseline
description: Concentration of adropin in serum
measure: Iron level in hair
time frame: Measured at baseline
description: The content of iron will be determined in hair (atomic absorption spectrometry)
measure: Zinc level in hair
time frame: Measured at baseline
description: The content of zinc will be determined in hair (atomic absorption spectrometry)
measure: Copper level in hair
time frame: Measured at baseline
description: The content of copper will be determined in hair (atomic absorption spectrometry)
measure: Iron level in serum
time frame: Measured at baseline
description: The content of iron will be determined in serum (atomic absorption spectrometry)
measure: Zinc level in serum
time frame: Measured at baseline
description: The content of zinc will be determined in serum (atomic absorption spectrometry)
measure: Copper level in serum
time frame: Measured at baseline
description: The content of copper will be determined in serum (atomic absorption spectrometry)
measure: Iron level in urine
time frame: Measured at baseline
description: The content of iron will be determined in urine (atomic absorption spectrometry)
measure: Zinc level in urine
time frame: Measured at baseline
description: The content of zinc will be determined in urine (atomic absorption spectrometry)
measure: Copper level in urine
time frame: Measured at baseline
description: The content of copper will be determined in urine (atomic absorption spectrometry)
measure: Body mass (BM)
time frame: Measured at baseline
description: Body mass
measure: Waist circumference (WC)
time frame: Measured at baseline
description: Waist circumference
measure: Hip circumference
time frame: Measured at baseline
description: Hip circumference
measure: Neck circumference
time frame: Measured at baseline
description: Neck circumference
measure: Body fat content
time frame: Measured at baseline
description: Body fat content in bioimpedance
measure: Muscle mass content
time frame: Measured at baseline
description: Muscle mass content in bioimpedance
measure: Total water content
time frame: Measured at baseline
description: Total water content in bioimpedance
measure: Systolic blood pressure
time frame: Measured at baseline
description: Measurement of systolic blood pressure
measure: Diastolic blood pressure
time frame: Measured at baseline
description: Measurement of diastolic blood pressure
measure: Pulse
time frame: Measured at baseline
description: Measurement of pulse
measure: Blood oxygen level
time frame: Measured at baseline
description: Measurement of blood oxygen level- measured non-invasively with the use of oximeter
measure: Total cholesterol (TCH)
time frame: Measured at baseline
description: Blood concentration of total cholesterol
measure: Low density lipoprotein (LDL)
time frame: Measured at baseline
description: Blood concentration of low density lipoprotein (LDL)
measure: High density lipoprotein (HDL)
time frame: Measured at baseline
description: Blood concentration of high density lipoprotein (HDL)
measure: Triglycerides
time frame: Measured at baseline
description: Blood concentration of triglycerides
measure: Glucose
time frame: Measured at baseline
description: Blood concentration of glucose
arm group label: Group A - study group - patients with metabolic syndrome
description: 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
arm group label: Group B - control group - patients without metabolic syndrome
description: 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
intervention type: Diagnostic Test
intervention name: Blood sample collection
description: 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.
arm group label: Group A - study group - patients with metabolic syndrome
arm group label: Group B - control group - patients without metabolic syndrome
intervention type: Diagnostic Test
intervention name: Hair sample collection
description: Hair sample collection will be performed. Hair mineral analysis will be performed.
arm group label: Group A - study group - patients with metabolic syndrome
arm group label: Group B - control group - patients without metabolic syndrome
intervention type: Diagnostic Test
intervention name: Urine sample collection
description: Urine sample collection will be performed. Urine mineral analysis will be performed.
arm group label: Group A - study group - patients with metabolic syndrome
arm group label: Group B - control group - patients without metabolic syndrome
intervention type: Diagnostic Test
intervention name: Body composition analysis
description: Body composition analysis with the use of electric bioimpedance will be performed.
arm group label: Group A - study group - patients with metabolic syndrome
arm group label: Group B - control group - patients without metabolic syndrome
intervention type: Diagnostic Test
intervention name: Questionnaires
description: Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.
arm group label: Group A - study group - patients with metabolic syndrome
arm group label: Group B - control group - patients without metabolic syndrome
intervention type: Diagnostic Test
intervention name: Blood pressure, pulse and blood oxygen saturation measurement
description: Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.
arm group label: Group A - study group - patients with metabolic syndrome
arm group label: Group B - control group - patients without metabolic syndrome
Samples of blood, hair and urine will be collected. From whole-blood samples of serum and
      plasma will be determined. From whole-blood genetic material will be isolated. Samples of
      serum, plasma, whole-blood, urine and serum will be signed with patient's unique code
      preventing patient's data identification. Only study team will have access to samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Damian Skrypnik, MD; PhD
role: Study Chair
affiliation: Poznan University of Medical Sciences
last name: Damian Skrypnik, MD, PhD
phone: +48 618549742
email: damian.skrypnik@gmail.com
last name: Agnieszka Wesołek, licentiate
phone: +48 618549742
email: aa.wesolek@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Obesity
mesh term: Overweight
mesh term: Metabolic Syndrome
mesh term: Dyslipidemias
mesh term: Glucose Metabolism Disorders
mesh term: Glucose Intolerance
mesh term: Nutrition Disorders
mesh term: Syndrome
sharing ipd: No