Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors

Polymorphism, Restriction Fragment Length Clinical Trial

— 27/MN/2018  

Official title:

Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors in People With Excessive Body Weight in the Polish Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077554
• Other study ID #: 359/15 & 1309/18
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2020
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 30, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Polymorphism, Restriction Fragment Length

Intervention

Genetic:
• gene expression
determination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration

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	VEGF gene expression	VEGF gene expression	through study completion, an average of 1 year
Primary	VEGF gene polymorphism	VEGF gene polymorphism	through study completion, an average of 1 year
Primary	serum leptin concentration	serum leptin concentration	through study completion, an average of 1 year
Secondary	Body mass (BM)	Body mass	through study completion, an average of 1 year
Secondary	Waist circumference (WC)	Waist circumference	through study completion, an average of 1 year
Secondary	total cholesterol (TCH)	Blood concentration of total cholesterol	through study completion, an average of 1 year
Secondary	low density lipoprotein (LDL)	Blood concentration of low density lipoprotein	through study completion, an average of 1 year
Secondary	high density lipoprotein (HDL)	Blood concentration of high density lipoprotein	through study completion, an average of 1 year
Secondary	triglycerides	Blood concentration of triglycerides	through study completion, an average of 1 year
Secondary	glucose	Blood concentration of glucose	through study completion, an average of 1 year