Polymorphism, Restriction Fragment Length27/MN/2018NCT04077554
Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors
An observational study of Polymorphism, Restriction Fragment Length, run by Poznan University of Medical Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Polymorphism, Restriction Fragment Length
- What is being tested?
- gene expression
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 30 Aug 2019
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
Poznan, Wielkopolska, 60-569
About this study
Official title: 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.
Read the 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.
- Being tested
- gene expression
- Keywords
- VEGF gene expression, VEGF gene polymorphism, leptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expressionGenetic
determination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration
| Study group | Role | What they receive |
|---|---|---|
| Study group | women and men with excess body mass Receives: Genetic: gene expression | |
| Control group | women and men with proper body mass Receives: Genetic: gene expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
VEGF gene expression
VEGF gene expression
Measured: through study completion, an average of 1 year
VEGF gene polymorphism
VEGF gene polymorphism
Measured: through study completion, an average of 1 year
serum leptin concentration
serum leptin concentration
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Body mass (BM)
Body mass
Measured: through study completion, an average of 1 year
Waist circumference (WC)
Waist circumference
Measured: through study completion, an average of 1 year
total cholesterol (TCH)
Blood concentration of total cholesterol
Measured: through study completion, an average of 1 year
low density lipoprotein (LDL)
Blood concentration of low density lipoprotein
Measured: through study completion, an average of 1 year
high density lipoprotein (HDL)
Blood concentration of high density lipoprotein
Measured: through study completion, an average of 1 year
triglycerides
Blood concentration of triglycerides
Measured: through study completion, an average of 1 year
glucose
Blood concentration of glucose
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polymorphism, Restriction Fragment LengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damian Skrypnik, MD, PhD, Poznan University of Medical Sciences
- Investigators
- Damian Skrypnik, MD; PhD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077554
- Sponsor's protocol ID
- 359/15 & 1309/18
- Acronym
- 27/MN/2018
- Status last verified
- Jun 2020
- First submitted
- 30 Aug 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32046348
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the VEGF Gene Polymorphism and Cardiometabolic Risk Factors in People With Excessive Body Weight in the Polish Population
- ClinicalTrials.gov ID
- NCT04077554
- Acronym / sponsor ID
- 27/MN/2018 / 359/15 & 1309/18
- Keywords
- VEGF gene expression, VEGF gene polymorphism, leptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Genetic: gene expressionwomen and men with excess body mass |
| Control group | – | Genetic: gene expressionwomen and men with proper body mass |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expressiondetermination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration | Genetic | Control group, Study group |
Primary outcome
VEGF gene expression
Time frame: through study completion, an average of 1 year
VEGF gene expression
VEGF gene polymorphism
Time frame: through study completion, an average of 1 year
VEGF gene polymorphism
serum leptin concentration
Time frame: through study completion, an average of 1 year
serum leptin concentration
7 secondary outcomes
Body mass (BM)
Time frame: through study completion, an average of 1 year
Waist circumference (WC)
Time frame: through study completion, an average of 1 year
total cholesterol (TCH)
Time frame: through study completion, an average of 1 year
low density lipoprotein (LDL)
Time frame: through study completion, an average of 1 year
high density lipoprotein (HDL)
Time frame: through study completion, an average of 1 year
triglycerides
Time frame: through study completion, an average of 1 year
glucose
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 32046348Skrypnik 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian Skrypnik, MD; PhD principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymorphism, Restriction Fragment Length, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VEGF gene expression (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.