Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome
NCT ID: NCT04451616
Last Updated: 2020-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2020-07-03
2021-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
Blood 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.
Hair sample collection
Hair sample collection will be performed. Hair mineral analysis will be performed.
Urine sample collection
Urine sample collection will be performed. Urine mineral analysis will be performed.
Body composition analysis
Body composition analysis with the use of electric bioimpedance will be performed.
Questionnaires
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
Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.
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
Blood 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.
Hair sample collection
Hair sample collection will be performed. Hair mineral analysis will be performed.
Urine sample collection
Urine sample collection will be performed. Urine mineral analysis will be performed.
Body composition analysis
Body composition analysis with the use of electric bioimpedance will be performed.
Questionnaires
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
Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.
Interventions
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Blood 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.
Hair sample collection
Hair sample collection will be performed. Hair mineral analysis will be performed.
Urine sample collection
Urine sample collection will be performed. Urine mineral analysis will be performed.
Body composition analysis
Body composition analysis with the use of electric bioimpedance will be performed.
Questionnaires
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
Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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Poznan University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Damian Skrypnik, MD; PhD
Role: STUDY_CHAIR
Poznan University of Medical Sciences
Locations
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Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
Poznan, Wielkopolska, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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353/20
Identifier Type: -
Identifier Source: org_study_id
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