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Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04451616
Acronym
PROG-FAM
Enrollment
80
Registered
2020-06-30
Start date
2020-07-03
Completion date
2021-06-01
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Obesity, Hypertension, Dyslipidemia, Progranulin, FAM19A5, Adipokines, Metabolic syndrome

Brief summary

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

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.

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.

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

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.

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

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ProgranulinMeasured at baselineConcentration of progranulin in serum
FAM19A5 ProteinMeasured at baselineConcentration of FAM19A5 protein in serum

Secondary

MeasureTime frameDescription
Systolic blood pressureMeasured at baselineMeasurement of systolic blood pressure
Diastolic blood pressureMeasured at baselineMeasurement of diastolic blood pressure
PulseMeasured at baselineMeasurement of pulse
Progranulin genesMeasured at baselineDetection and testing of progranulin genes
FAM19A5 protein genesMeasured at baselineDetection and testing of FAM19A5 protein genes
LeptinMeasured at baselineConcentration of leptin in serum
Vascular endothelial growth factor (VGEF)Measured at baselineConcentration of VGEF in serum
InsulinMeasured at baselineConcentration of insulin in serum
NeopterinMeasured at baselineConcentration of neopterin in serum
AdropinMeasured at baselineConcentration of adropin in serum
Iron level in hairMeasured at baselineThe content of iron will be determined in hair (atomic absorption spectrometry)
Zinc level in hairMeasured at baselineThe content of zinc will be determined in hair (atomic absorption spectrometry)
Copper level in hairMeasured at baselineThe content of copper will be determined in hair (atomic absorption spectrometry)
Iron level in serumMeasured at baselineThe content of iron will be determined in serum (atomic absorption spectrometry)
Zinc level in serumMeasured at baselineThe content of zinc will be determined in serum (atomic absorption spectrometry)
Muscle mass contentMeasured at baselineMuscle mass content in bioimpedance
Iron level in urineMeasured at baselineThe content of iron will be determined in urine (atomic absorption spectrometry)
Zinc level in urineMeasured at baselineThe content of zinc will be determined in urine (atomic absorption spectrometry)
Copper level in urineMeasured at baselineThe content of copper will be determined in urine (atomic absorption spectrometry)
Body mass (BM)Measured at baselineBody mass
Waist circumference (WC)Measured at baselineWaist circumference
Hip circumferenceMeasured at baselineHip circumference
Neck circumferenceMeasured at baselineNeck circumference
Body fat contentMeasured at baselineBody fat content in bioimpedance
Blood oxygen levelMeasured at baselineMeasurement of blood oxygen level- measured non-invasively with the use of oximeter
Total cholesterol (TCH)Measured at baselineBlood concentration of total cholesterol
Low density lipoprotein (LDL)Measured at baselineBlood concentration of low density lipoprotein (LDL)
High density lipoprotein (HDL)Measured at baselineBlood concentration of high density lipoprotein (HDL)
TriglyceridesMeasured at baselineBlood concentration of triglycerides
GlucoseMeasured at baselineBlood concentration of glucose
Copper level in serumMeasured at baselineThe content of copper will be determined in serum (atomic absorption spectrometry)
Total water contentMeasured at baselineTotal water content in bioimpedance

Countries

Poland

Contacts

Primary ContactDamian Skrypnik, MD, PhD
damian.skrypnik@gmail.com+48 618549742
Backup ContactAgnieszka Wesołek, licentiate
aa.wesolek@gmail.com+48 618549742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026