Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome

Obesity Clinical Trial

— PROG-FAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451616
• Other study ID #: 353/20
• Status: Recruiting
• Start date: July 3, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2020
• Source: Poznan University of Medical Sciences
• Contact: Damian Skrypnik, MD, PhD
• Phone: +48 618549742
• Email: damian.skrypnik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Poland	Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progranulin	Concentration of progranulin in serum	Measured at baseline
Primary	FAM19A5 Protein	Concentration of FAM19A5 protein in serum	Measured at baseline
Secondary	Progranulin genes	Detection and testing of progranulin genes	Measured at baseline
Secondary	FAM19A5 protein genes	Detection and testing of FAM19A5 protein genes	Measured at baseline
Secondary	Leptin	Concentration of leptin in serum	Measured at baseline
Secondary	Vascular endothelial growth factor (VGEF)	Concentration of VGEF in serum	Measured at baseline
Secondary	Insulin	Concentration of insulin in serum	Measured at baseline
Secondary	Neopterin	Concentration of neopterin in serum	Measured at baseline
Secondary	Adropin	Concentration of adropin in serum	Measured at baseline
Secondary	Iron level in hair	The content of iron will be determined in hair (atomic absorption spectrometry)	Measured at baseline
Secondary	Zinc level in hair	The content of zinc will be determined in hair (atomic absorption spectrometry)	Measured at baseline
Secondary	Copper level in hair	The content of copper will be determined in hair (atomic absorption spectrometry)	Measured at baseline
Secondary	Iron level in serum	The content of iron will be determined in serum (atomic absorption spectrometry)	Measured at baseline
Secondary	Zinc level in serum	The content of zinc will be determined in serum (atomic absorption spectrometry)	Measured at baseline
Secondary	Copper level in serum	The content of copper will be determined in serum (atomic absorption spectrometry)	Measured at baseline
Secondary	Iron level in urine	The content of iron will be determined in urine (atomic absorption spectrometry)	Measured at baseline
Secondary	Zinc level in urine	The content of zinc will be determined in urine (atomic absorption spectrometry)	Measured at baseline
Secondary	Copper level in urine	The content of copper will be determined in urine (atomic absorption spectrometry)	Measured at baseline
Secondary	Body mass (BM)	Body mass	Measured at baseline
Secondary	Waist circumference (WC)	Waist circumference	Measured at baseline
Secondary	Hip circumference	Hip circumference	Measured at baseline
Secondary	Neck circumference	Neck circumference	Measured at baseline
Secondary	Body fat content	Body fat content in bioimpedance	Measured at baseline
Secondary	Muscle mass content	Muscle mass content in bioimpedance	Measured at baseline
Secondary	Total water content	Total water content in bioimpedance	Measured at baseline
Secondary	Systolic blood pressure	Measurement of systolic blood pressure	Measured at baseline
Secondary	Diastolic blood pressure	Measurement of diastolic blood pressure	Measured at baseline
Secondary	Pulse	Measurement of pulse	Measured at baseline
Secondary	Blood oxygen level	Measurement of blood oxygen level- measured non-invasively with the use of oximeter	Measured at baseline
Secondary	Total cholesterol (TCH)	Blood concentration of total cholesterol	Measured at baseline
Secondary	Low density lipoprotein (LDL)	Blood concentration of low density lipoprotein (LDL)	Measured at baseline
Secondary	High density lipoprotein (HDL)	Blood concentration of high density lipoprotein (HDL)	Measured at baseline
Secondary	Triglycerides	Blood concentration of triglycerides	Measured at baseline
Secondary	Glucose	Blood concentration of glucose	Measured at baseline