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Completed

NCT Number: NCT04077554

Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors

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.

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Key information

Conditions

Polymorphism, Restriction Fragment Length

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences

Poznan, Wielkopolska, 60-569, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gene expression

Genetic

determination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration

Primary outcomes

  1. VEGF gene expression

    Time frame: through study completion, an average of 1 year

    VEGF gene expression

  2. VEGF gene polymorphism

    Time frame: through study completion, an average of 1 year

    VEGF gene polymorphism

  3. serum leptin concentration

    Time frame: through study completion, an average of 1 year

    serum leptin concentration

Secondary outcomes

  1. Body mass (BM)

    Time frame: through study completion, an average of 1 year

    Body mass

  2. Waist circumference (WC)

    Time frame: through study completion, an average of 1 year

    Waist circumference

  3. total cholesterol (TCH)

    Time frame: through study completion, an average of 1 year

    Blood concentration of total cholesterol

  4. low density lipoprotein (LDL)

    Time frame: through study completion, an average of 1 year

    Blood concentration of low density lipoprotein

  5. high density lipoprotein (HDL)

    Time frame: through study completion, an average of 1 year

    Blood concentration of high density lipoprotein

  6. triglycerides

    Time frame: through study completion, an average of 1 year

    Blood concentration of triglycerides

  7. glucose

    Time frame: through study completion, an average of 1 year

    Blood concentration of glucose

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: 27/MN/2018

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 4, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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