Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome (PROG-FAM)
Assessment of Progranulin and Chemokine-like Protein TAFA-5 (FAM19A5) Blood Levels in Adults With Metabolic Syndrome
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Damian Skrypnik, MD, PhD
- Phone Number: +48 618549742
- Email: damian.skrypnik@gmail.com
Study Contact Backup
- Name: Agnieszka Wesołek, licentiate
- Phone Number: +48 618549742
- Email: aa.wesolek@gmail.com
Study Locations
-
-
Wielkopolska
-
Poznan, Wielkopolska, Poland, 60-569
- Recruiting
- Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Group A - study group - patients with metabolic syndrome
Patients with metabolic syndrome will be included. Procedures:
|
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 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.
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.
|
|
Group B - control group - patients without metabolic syndrome
Patients without metabolic syndrome will be included.
|
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 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progranulin
Time Frame: Measured at baseline
|
Concentration of progranulin in serum
|
Measured at baseline
|
|
FAM19A5 Protein
Time Frame: Measured at baseline
|
Concentration of FAM19A5 protein in serum
|
Measured at baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progranulin genes
Time Frame: Measured at baseline
|
Detection and testing of progranulin genes
|
Measured at baseline
|
|
FAM19A5 protein genes
Time Frame: Measured at baseline
|
Detection and testing of FAM19A5 protein genes
|
Measured at baseline
|
|
Leptin
Time Frame: Measured at baseline
|
Concentration of leptin in serum
|
Measured at baseline
|
|
Vascular endothelial growth factor (VGEF)
Time Frame: Measured at baseline
|
Concentration of VGEF in serum
|
Measured at baseline
|
|
Insulin
Time Frame: Measured at baseline
|
Concentration of insulin in serum
|
Measured at baseline
|
|
Neopterin
Time Frame: Measured at baseline
|
Concentration of neopterin in serum
|
Measured at baseline
|
|
Adropin
Time Frame: Measured at baseline
|
Concentration of adropin in serum
|
Measured at baseline
|
|
Iron level in hair
Time Frame: Measured at baseline
|
The content of iron will be determined in hair (atomic absorption spectrometry)
|
Measured at baseline
|
|
Zinc level in hair
Time Frame: Measured at baseline
|
The content of zinc will be determined in hair (atomic absorption spectrometry)
|
Measured at baseline
|
|
Copper level in hair
Time Frame: Measured at baseline
|
The content of copper will be determined in hair (atomic absorption spectrometry)
|
Measured at baseline
|
|
Iron level in serum
Time Frame: Measured at baseline
|
The content of iron will be determined in serum (atomic absorption spectrometry)
|
Measured at baseline
|
|
Zinc level in serum
Time Frame: Measured at baseline
|
The content of zinc will be determined in serum (atomic absorption spectrometry)
|
Measured at baseline
|
|
Copper level in serum
Time Frame: Measured at baseline
|
The content of copper will be determined in serum (atomic absorption spectrometry)
|
Measured at baseline
|
|
Iron level in urine
Time Frame: Measured at baseline
|
The content of iron will be determined in urine (atomic absorption spectrometry)
|
Measured at baseline
|
|
Zinc level in urine
Time Frame: Measured at baseline
|
The content of zinc will be determined in urine (atomic absorption spectrometry)
|
Measured at baseline
|
|
Copper level in urine
Time Frame: Measured at baseline
|
The content of copper will be determined in urine (atomic absorption spectrometry)
|
Measured at baseline
|
|
Body mass (BM)
Time Frame: Measured at baseline
|
Body mass
|
Measured at baseline
|
|
Waist circumference (WC)
Time Frame: Measured at baseline
|
Waist circumference
|
Measured at baseline
|
|
Hip circumference
Time Frame: Measured at baseline
|
Hip circumference
|
Measured at baseline
|
|
Neck circumference
Time Frame: Measured at baseline
|
Neck circumference
|
Measured at baseline
|
|
Body fat content
Time Frame: Measured at baseline
|
Body fat content in bioimpedance
|
Measured at baseline
|
|
Muscle mass content
Time Frame: Measured at baseline
|
Muscle mass content in bioimpedance
|
Measured at baseline
|
|
Total water content
Time Frame: Measured at baseline
|
Total water content in bioimpedance
|
Measured at baseline
|
|
Systolic blood pressure
Time Frame: Measured at baseline
|
Measurement of systolic blood pressure
|
Measured at baseline
|
|
Diastolic blood pressure
Time Frame: Measured at baseline
|
Measurement of diastolic blood pressure
|
Measured at baseline
|
|
Pulse
Time Frame: Measured at baseline
|
Measurement of pulse
|
Measured at baseline
|
|
Blood oxygen level
Time Frame: Measured at baseline
|
Measurement of blood oxygen level- measured non-invasively with the use of oximeter
|
Measured at baseline
|
|
Total cholesterol (TCH)
Time Frame: Measured at baseline
|
Blood concentration of total cholesterol
|
Measured at baseline
|
|
Low density lipoprotein (LDL)
Time Frame: Measured at baseline
|
Blood concentration of low density lipoprotein (LDL)
|
Measured at baseline
|
|
High density lipoprotein (HDL)
Time Frame: Measured at baseline
|
Blood concentration of high density lipoprotein (HDL)
|
Measured at baseline
|
|
Triglycerides
Time Frame: Measured at baseline
|
Blood concentration of triglycerides
|
Measured at baseline
|
|
Glucose
Time Frame: Measured at baseline
|
Blood concentration of glucose
|
Measured at baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Damian Skrypnik, MD; PhD, Poznan University of Medical Sciences
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Overnutrition
- Body Weight
- Insulin Resistance
- Hyperinsulinism
- Hyperglycemia
- Lipid Metabolism Disorders
- Hypertension
- Syndrome
- Obesity
- Disease
- Metabolic Syndrome
- Glucose Intolerance
- Dyslipidemias
- Overweight
- Nutrition Disorders
- Glucose Metabolism Disorders
Other Study ID Numbers
Other Study ID Numbers
- 353/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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