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

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

Study Overview

• Status: Unknown
• Conditions: Glucose Metabolism Disorders; Hypertension; Obesity; Nutrition Disorders; Metabolic Syndrome; Dyslipidemias; Glucose Intolerance; Overweight and Obesity
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• 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

• Poland
  • 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

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A - study group - patients with metabolic syndrome; Patients with metabolic syndrome will be included. Procedures: blood sample collection; hair sample collection; urine sample collection; body composition analysis; questionnaires; blood pressure, pulse and blood oxygen saturation measurement	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.; Diagnostic test: Hair sample collection; Hair sample collection will be performed. Hair mineral analysis will be performed.; Diagnostic test: Urine sample collection; Urine sample collection will be performed. Urine mineral analysis will be performed.; Diagnostic test: Body composition analysis; Body composition analysis with the use of electric bioimpedance will be performed.; Diagnostic test: Questionnaires; Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.; Diagnostic test: 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.; blood sample collection; hair sample collection; urine sample collection; body composition analysis; questionnaires; blood pressure, pulse and blood oxygen saturation measurement	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.; Diagnostic test: Hair sample collection; Hair sample collection will be performed. Hair mineral analysis will be performed.; Diagnostic test: Urine sample collection; Urine sample collection will be performed. Urine mineral analysis will be performed.; Diagnostic test: Body composition analysis; Body composition analysis with the use of electric bioimpedance will be performed.; Diagnostic test: Questionnaires; Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.; Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progranulin	Concentration of progranulin in serum	Measured at baseline
FAM19A5 Protein	Concentration of FAM19A5 protein in serum	Measured at baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Damian Skrypnik, MD; PhD, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (ACTUAL): June 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Metabolic syndrome; Dyslipidemia; Hypertension; Adipokines; Progranulin; FAM19A5
• 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: 353/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No