Assessment of Progranulin and FAM19A5 Protein Blood Levels in Metabolic Syndrome (PROG-FAM)

Poznan University of Medical Sciences (PUMS)

Status: Unknown

Conditions: Hypertension; Nutrition Disorders; Dyslipidemias; Glucose Metabolism Disorders; Overweight and Obesity; Obesity; Metabolic Syndrome; Glucose Intolerance

Treatments: Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurement; Diagnostic Test: Hair sample collection; Diagnostic Test: Body composition analysis; Diagnostic Test: Questionnaires; Diagnostic Test: Blood sample collection; Diagnostic Test: Urine sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT04451616

353/20

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Group A - study group - patients with metabolic syndrome

Description:

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

Treatment:

Diagnostic Test: Urine sample collection

Diagnostic Test: Hair sample collection

Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurement

Diagnostic Test: Body composition analysis

Diagnostic Test: Blood sample collection

Diagnostic Test: Questionnaires

Group B - control group - patients without metabolic syndrome

Description:

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

Treatment:

Diagnostic Test: Urine sample collection

Diagnostic Test: Hair sample collection

Diagnostic Test: Blood pressure, pulse and blood oxygen saturation measurement

Diagnostic Test: Body composition analysis

Diagnostic Test: Blood sample collection

Diagnostic Test: Questionnaires