Clinical trial NCT04451616: Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome
Official title: Assessment of Progranulin and Chemokine-like Protein TAFA-5 (FAM19A5) Blood Levels in Adults With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progranulin
timeFrame: Measured at baseline
measure: FAM19A5 Protein
timeFrame: Measured at baseline
Secondary outcomes:
measure: Progranulin genes
timeFrame: Measured at baseline
measure: FAM19A5 protein genes
timeFrame: Measured at baseline
measure: Leptin
timeFrame: Measured at baseline
measure: Vascular endothelial growth factor (VGEF)
timeFrame: Measured at baseline
measure: Insulin
timeFrame: Measured at baseline
measure: Neopterin
timeFrame: Measured at baseline
measure: Adropin
timeFrame: Measured at baseline
measure: Iron level in hair
timeFrame: Measured at baseline
measure: Zinc level in hair
timeFrame: Measured at baseline
measure: Copper level in hair
timeFrame: Measured at baseline
measure: Iron level in serum
timeFrame: Measured at baseline
measure: Zinc level in serum
timeFrame: Measured at baseline
measure: Copper level in serum
timeFrame: Measured at baseline
measure: Iron level in urine
timeFrame: Measured at baseline
measure: Zinc level in urine
timeFrame: Measured at baseline
measure: Copper level in urine
timeFrame: Measured at baseline
measure: Body mass (BM)
timeFrame: Measured at baseline
measure: Waist circumference (WC)
timeFrame: Measured at baseline
measure: Hip circumference
timeFrame: Measured at baseline
measure: Neck circumference
timeFrame: Measured at baseline
measure: Body fat content
timeFrame: Measured at baseline
measure: Muscle mass content
timeFrame: Measured at baseline
measure: Total water content
timeFrame: Measured at baseline
measure: Systolic blood pressure
timeFrame: Measured at baseline
measure: Diastolic blood pressure
timeFrame: Measured at baseline
measure: Pulse
timeFrame: Measured at baseline
measure: Blood oxygen level
timeFrame: Measured at baseline
measure: Total cholesterol (TCH)
timeFrame: Measured at baseline
measure: Low density lipoprotein (LDL)
timeFrame: Measured at baseline
measure: High density lipoprotein (HDL)
timeFrame: Measured at baseline
measure: Triglycerides
timeFrame: Measured at baseline
measure: Glucose
timeFrame: Measured at baseline
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
state: Wielkopolska
Study officials:
affiliation: Poznan University of Medical Sciences
name: Damian Skrypnik, MD; PhD
role: STUDY_CHAIR
References: