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Status unknownNCT04451616PROG-FAMUpdated Aug 14, 2020

Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome

An observational study in Nutrition Disorders, Hypertension and Dyslipidemias, sponsored by Poznan University of Medical Sciences. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-14.

Sponsored by Poznan University of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

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

Keywords

  • Obesity
  • Hypertension
  • Dyslipidemia
  • Progranulin
  • FAM19A5
  • Adipokines
  • Metabolic syndrome
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 80 is below the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

40 people (women and men) with metabolic syndrome (study group) and 40 people (women and men) without metabolic syndrome (control group).

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group A - study group - patients with metabolic syndrome

    Patients with metabolic syndrome will be included. Procedures: 1. blood sample collection 2. hair sample collection 3. urine sample collection 4. body composition analysis 5. questionnaires 6. blood pressure, pulse and blood oxygen saturation measurement

    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

  • Group B - control group - patients without metabolic syndrome

    Patients without metabolic syndrome will be included. 1. blood sample collection 2. hair sample collection 3. urine sample collection 4. body composition analysis 5. questionnaires 6. blood pressure, pulse and blood oxygen saturation measurement

    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

Interventions

  • Diagnostic testBlood sample collection

    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.

  • Diagnostic testHair sample collection

    Hair sample collection will be performed. Hair mineral analysis will be performed.

  • Diagnostic testUrine sample collection

    Urine sample collection will be performed. Urine mineral analysis will be performed.

  • Diagnostic testBody composition analysis

    Body composition analysis with the use of electric bioimpedance will be performed.

  • Diagnostic testQuestionnaires

    Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.

  • Diagnostic testBlood pressure, pulse and blood oxygen saturation measurement

    Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.

06

What researchers measure

Primary outcomes

  1. Progranulin

    Concentration of progranulin in serum

    Time frame: Measured at baseline

  2. FAM19A5 Protein

    Concentration of FAM19A5 protein in serum

    Time frame: Measured at baseline

Secondary outcomes

  1. Progranulin genes

    Detection and testing of progranulin genes

    Time frame: Measured at baseline

  2. FAM19A5 protein genes

    Detection and testing of FAM19A5 protein genes

    Time frame: Measured at baseline

  3. Leptin

    Concentration of leptin in serum

    Time frame: Measured at baseline

  4. Vascular endothelial growth factor (VGEF)

    Concentration of VGEF in serum

    Time frame: Measured at baseline

  5. Insulin

    Concentration of insulin in serum

    Time frame: Measured at baseline

  6. Neopterin

    Concentration of neopterin in serum

    Time frame: Measured at baseline

  7. Adropin

    Concentration of adropin in serum

    Time frame: Measured at baseline

  8. Iron level in hair

    The content of iron will be determined in hair (atomic absorption spectrometry)

    Time frame: Measured at baseline

  9. Zinc level in hair

    The content of zinc will be determined in hair (atomic absorption spectrometry)

    Time frame: Measured at baseline

  10. Copper level in hair

    The content of copper will be determined in hair (atomic absorption spectrometry)

    Time frame: Measured at baseline

  11. Iron level in serum

    The content of iron will be determined in serum (atomic absorption spectrometry)

    Time frame: Measured at baseline

  12. Zinc level in serum

    The content of zinc will be determined in serum (atomic absorption spectrometry)

    Time frame: Measured at baseline

  13. Copper level in serum

    The content of copper will be determined in serum (atomic absorption spectrometry)

    Time frame: Measured at baseline

  14. Iron level in urine

    The content of iron will be determined in urine (atomic absorption spectrometry)

    Time frame: Measured at baseline

  15. Zinc level in urine

    The content of zinc will be determined in urine (atomic absorption spectrometry)

    Time frame: Measured at baseline

  16. Copper level in urine

    The content of copper will be determined in urine (atomic absorption spectrometry)

    Time frame: Measured at baseline

  17. Body mass (BM)

    Body mass

    Time frame: Measured at baseline

  18. Waist circumference (WC)

    Waist circumference

    Time frame: Measured at baseline

  19. Hip circumference

    Hip circumference

    Time frame: Measured at baseline

  20. Neck circumference

    Neck circumference

    Time frame: Measured at baseline

  21. Body fat content

    Body fat content in bioimpedance

    Time frame: Measured at baseline

  22. Muscle mass content

    Muscle mass content in bioimpedance

    Time frame: Measured at baseline

  23. Total water content

    Total water content in bioimpedance

    Time frame: Measured at baseline

  24. Systolic blood pressure

    Measurement of systolic blood pressure

    Time frame: Measured at baseline

  25. Diastolic blood pressure

    Measurement of diastolic blood pressure

    Time frame: Measured at baseline

  26. Pulse

    Measurement of pulse

    Time frame: Measured at baseline

  27. Blood oxygen level

    Measurement of blood oxygen level- measured non-invasively with the use of oximeter

    Time frame: Measured at baseline

  28. Total cholesterol (TCH)

    Blood concentration of total cholesterol

    Time frame: Measured at baseline

  29. Low density lipoprotein (LDL)

    Blood concentration of low density lipoprotein (LDL)

    Time frame: Measured at baseline

  30. High density lipoprotein (HDL)

    Blood concentration of high density lipoprotein (HDL)

    Time frame: Measured at baseline

  31. Triglycerides

    Blood concentration of triglycerides

    Time frame: Measured at baseline

  32. Glucose

    Blood concentration of glucose

    Time frame: Measured at baseline

07

Study locations

1 of 1 sites recruiting
  • Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
    Poznan, Wielkopolska 60-569, Poland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04451616
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Sponsor
First posted
Jun 30, 2020
Start date
Jul 3, 2020
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 1, 2021 (estimated)
Last update
Aug 14, 2020

Study contacts

Damian Skrypnik, MD, PhD
Contact
damian.skrypnik@gmail.com
+48 618549742
Agnieszka Wesołek, licentiate
Contact
aa.wesolek@gmail.com
+48 618549742
Damian Skrypnik, MD; PhD
study chair · Poznan University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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