Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors (27/MN/2018)

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

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.

Study Overview

• Status: Completed
• Conditions: Polymorphism, Restriction Fragment Length
• Intervention / Treatment: Genetic: gene expression

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 60-569
      • Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; women and men with excess body mass	Genetic: gene expression; determination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration
Control group; women and men with proper body mass	Genetic: gene expression; determination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VEGF gene expression	VEGF gene expression	through study completion, an average of 1 year
VEGF gene polymorphism	VEGF gene polymorphism	through study completion, an average of 1 year
serum leptin concentration	serum leptin concentration	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass (BM)	Body mass	through study completion, an average of 1 year
Waist circumference (WC)	Waist circumference	through study completion, an average of 1 year
total cholesterol (TCH)	Blood concentration of total cholesterol	through study completion, an average of 1 year
low density lipoprotein (LDL)	Blood concentration of low density lipoprotein	through study completion, an average of 1 year
high density lipoprotein (HDL)	Blood concentration of high density lipoprotein	through study completion, an average of 1 year
triglycerides	Blood concentration of triglycerides	through study completion, an average of 1 year
glucose	Blood concentration of glucose	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Damian Skrypnik, MD; PhD, Poznan University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: leptin; VEGF gene expression; VEGF gene polymorphism
• Other Study ID Numbers: 359/15 & 1309/18

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