Relationship Between the VEGF Gene Polymorphism and Cardi... | NCT04077554

Studies
Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors

NCT04077554

Sponsor

Poznan University of Medical Sciences

Status

Completed

Last Update Posted

Jun 4, 2020Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Polymorphism, Restriction Fragment Length

Interventions

gene expression

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Aug 30, 2019

First Submission Date that Met QC Criteria

Sep 2, 2019

First Posted Date

Sep 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Damian Skrypnik, MD, PhD, Principial Investigator, Poznan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Poznan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
gene expression	Genetic	determination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration	Control group Study group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Damian Skrypnik, MD; PhD	Poznan University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences		Poznan	Wielkopolska	60-569	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32046348	Derived	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.