Clinical trial NCT04077554: Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors
Official title: Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors in People With Excessive Body Weight in the Polish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymorphism, Restriction Fragment Length
Keywords: VEGF gene expression
VEGF gene polymorphism
leptin
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 195/5000 250 people (women and men) with excessive body weight (BMI ≥ 25 kg / m2 - study group) and 150 people (women and men) with normal body weight (BMI \<25 kg / m2 - control group) from Poland.

Brief summary: The aim of the study is to determine the relationship between VEGF gene expression, VEGF gene polymorphism and serum leptin concentration in the Polish population in people with excessive body weight. In addition, the aim of the study is to look for relationships between the VEGF gene polymorphism and anthropometric and biochemical factors of cardiovascular risk and endothelial dysfunction such as body weight, waist circumference, serum total cholesterol, LDL, HDL, triglycerides, glucose and the occurrence of cardiovascular diseases in the family of a patient with excessive body weight in the Polish population.

Detailed description: 400 people (250 - study group; 150 control group) were subjected to subjective and objective action. Information on the occurrence of diseases and cardiovascular risk in the participant and his family was collected from research studies. Anthropometric parameters were measured (body weight, height, BMI, waist circumference, neck circumference) as well as blood pressure and pulse measurement. In addition, fasting venous blood was collected and secured. In venous blood currently marked with the following concentration: glucose, required cholesterol, LDL cholesterol, HDL cholesterol and triglycerides. In addition, a method of salting out and protecting DNA was developed from blood.

Furthermore the polymorphisms of VEGF genes (in positions: -2578 and -634) using the HMR (High Resolution Melt) method was determined.

Also VEGF and leptin by ELISA was determined. After obtaining the results of comparative analysis of the correlation between the occurrence of VEGF gene polymorphisms, serum levels of leptin and VEGF, and anthropometric and biochemical parameters of cardiovascular risk.

Eligibility criteria: Inclusion Criteria:

* informed consent in writing
* stable body mass (+/- 1 kg)
* excessive body mass (BMI ≥ 25 kg/m2- study group)
* proper body mass (BMI \< 25 kg/m2- control group)

Exclusion Criteria:

* age \<18 years
* secondary obesity
* pregnancy, lactation
* other conditions that in the opinion of researchers may pose any risk to the patient during the study.

Primary outcomes:
measure: VEGF gene expression
timeFrame: through study completion, an average of 1 year
measure: VEGF gene polymorphism
timeFrame: through study completion, an average of 1 year
measure: serum leptin concentration
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Body mass (BM)
timeFrame: through study completion, an average of 1 year
measure: Waist circumference (WC)
timeFrame: through study completion, an average of 1 year
measure: total cholesterol (TCH)
timeFrame: through study completion, an average of 1 year
measure: low density lipoprotein (LDL)
timeFrame: through study completion, an average of 1 year
measure: high density lipoprotein (HDL)
timeFrame: through study completion, an average of 1 year
measure: triglycerides
timeFrame: through study completion, an average of 1 year
measure: glucose
timeFrame: through study completion, an average of 1 year
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: PRINCIPAL_INVESTIGATOR
References:
citation: Skrypnik D, Mostowska A, Jagodzinski PP, Bogdanski P. Association of rs699947 (-2578 C/A) and rs2010963 (-634 G/C) Single Nucleotide Polymorphisms of the VEGF Gene, VEGF-A and Leptin Serum Level, and Cardiovascular Risk in Patients with Excess Body Mass: A Case-Control Study. J Clin Med. 2020 Feb 8;9(2):469. doi: 10.3390/jcm9020469.