NCT04077554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

Same day

First QC Date

August 30, 2019

Last Update Submit

June 2, 2020

Conditions

Polymorphism, Restriction Fragment Length

Keywords

VEGF gene expressionVEGF gene polymorphismleptin

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Body mass (BM)

    through study completion, an average of 1 year

  • Waist circumference (WC)

    through study completion, an average of 1 year

  • total cholesterol (TCH)

    through study completion, an average of 1 year

  • low density lipoprotein (LDL)

    through study completion, an average of 1 year

  • high density lipoprotein (HDL)

    through study completion, an average of 1 year

  • +2 more secondary outcomes

Study Arms (2)

Study group

women and men with excess body mass

Genetic: gene expression

Control group

women and men with proper body mass

Genetic: gene expression

Interventions

gene expressionGENETIC

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

Control groupStudy group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Poznan, Wielkopolska, 60-569, Poland

Location

Related Publications (1)

  • 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.

    PMID: 32046348DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

salting out method was developed from blood and DNA was protected.

MeSH Terms

Interventions

Gene Expression

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Damian Skrypnik, MD; PhD

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principial Investigator

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 4, 2019

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

August 30, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)