Obesity, VisceralNCT05789888
Genes Variability in Obesity and Normal Body Weight Patients.
An observational study of Obesity, Visceral and Obesity, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
The goal of this clinical trial is to learn about variability of gene SCD and MT-ATP6 in describe participant population and health conditions. The main questions it aims to answer are: whether there is variation in genes between obese and normal weight individuals Participants will get body weight and high was… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Obesity, Visceral, Obesity
- What is being tested?
- MT-ATP6 mtDNA gene variability in obesity and normal body weight patients., SCD gene variability in obesity and normal body weight patients. and Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.
- How many people
- 116 participants
- Where
- 1 sitePoland
- Study dates
- 10 Apr 2021to 1 Jan 2023
- 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 20 to 55 years
- All sexes
- Adult
Study population: Inhabitants of the Podlaskie Voivodeship.
Who may be able to join
- primary obesity and normal body weight
Who cannot join
- absence of inflammation and periodontal disease in the oral cavity
- secondary obesity
- type 1 diabetes
- type 2 diabetes
- endocrine disorders
- appetite disorders
Show all 11Show fewer
- pregnancy and lactation
- acute coronary artery disease
- use of hormonal contraception or hormone replacement therapy
- steroid therapy
- antiretroviral therapy, previous surgical or pharmacological treatment for obesity and pacemaker
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-089
About this study
Official title: Evaluation of the Influence of SNP Variability of Stearoyl-CoA Desaturase (SCD) Gene of Nuclear DNA and MT-ATP6 Gene of Mitochondrial DNA and Environmental Factors on Phenotypic Variability of Visceral and Subcutaneous Adipose Tissue
The goal of this clinical trial is to learn about variability of gene SCD and MT-ATP6 in describe participant population and health conditions. The main questions it aims to answer are:
- whether there is variation in genes between obese and normal weight individuals
Participants will get body weight and high was assessed using the medical scale and stadiometer, then, basis on obtained results, the Body Mass Index (BMI) will be calculated. Next, participants get determine the body composition and body composition analysis by bioelectrical impedance method to determined: Visceral Adipose Tissue (VAT in cm2 and %), Subcutaneous Adipose Tissue (SAT in cm2 and %), and the VAT/SAT ratio was also determined. Then order to examine the sequence of the genes, swab will take from the oral cavity (cheeks and palate) using sterile swab. The research was carried out at the Department of Dietetics and Clinical Nutrition (Medical University of Bialystok).
Read the detailed description
The approved of the Bioethics Committee of the Medical University, No. APK.002.407.2020, was obtained for the study. 116 people meeting the inclusion criteria were included in the intervention and observational study. The research was carried out at the Department of Dietetics and Clinical Nutrition at the Faculty of Health Sciences of the Medical University of Bialystok.
The study took place from the April to the September 2021. The analysis were performed in the morning, fasting, without intensive physical ac-tivity. Body weight and high was assessed using the medical scale and stadiometer with an accuracy of 0.01 kg for the body weight and 0.5 cm for the body high. Then, basis on obtained results, the Body Mass Index (BMI) was calculated.Basis on the obtained results the participants were divided into the study group (n=75) and control group (n=41). The study group consisted 46 women and 29 men with primary obesity (BMI=30.0-39.9 kg/m2). The control group consisted 31 women and 10 men with normal body weight (BMI=18.5-24.9 kg/m2).
In order to determine the body composition of participants, a body composition analysis by bioelectrical impedance method was conducted, which enabled the assessment of the following parameters: total body fat mass (kg), total percentage of body fat (%), total percentage of free fat mass (%). The area of adipose tissue in the transverse section to the abdomen was also deter-mined: Visceral Adipose Tissue (VAT in cm2 and %), Subcutaneous Adipose Tissue (SAT in cm2 and %), and the VAT/SAT ratio was also determined. To determine the TOFI phenotype of abdominal fat distribution VAT/SAT ratio was used- above 1 for men and above 0.9 for women.
Next swab from the oral cavity was took. To isolate DNA from the swabs, was used ready kit from A\&A Biotechnology. After it we did the PCR reactions with the appropriate primers and clean up after PCR reaction was did. Next we prepared the samples for Sanger sequencing.
When we get the sequences, we used the genetics programs: Bioedit, Chromas, DnaSP, Arlequin, Mega, Genepop to get number of haplotypes, genes variability, F statistics, haplotype diversity, haplotypes network and genetic tree of haplotypes.
- Conditions
- Obesity, Visceral, Obesity
- Being tested
- MT-ATP6 mtDNA gene variability in obesity and normal body weight patients., SCD gene variability in obesity and normal body weight patients., Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.
- Keywords
- SCD, MT-ATP6, Obesity, VAT, SAT, TOFI, FOTI, Genetic, Genes, Phenotype
- Medical subject headings
- Obesity, Abdominal, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-ATP6 mtDNA gene variability in obesity and normal body weight patients.Genetic
Also called The search for obesity markers
As part of the research, the MT-ATP6 gene was tested in order to influence the modulation of the amount of fat contained.
SCD gene variability in obesity and normal body weight patients.Genetic
Also called The search for obesity markers
As part of the research, the SCD gene was tested in order to influence the modulation of the amount of fat contained.
Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.Other
Also called Phenotypes in obesity
As part of the research, we measured the amount of VAT and SAT and calculate VAT/SAT ratio as a marker to determine the phenotype of fat tissue.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The study group consisted of 75 people (46 women and 29 men) with gender (BMI=30.0-39.9 kg/m2). Receives: Genetic: MT-ATP6 mtDNA gene variability in obesity and normal body weight patients.; Genetic: SCD gene variability in obesity and normal body weight patients.; Other: Finding TOFI and FOTI phenotypes in participants with obesity and normal weight. | |
| Control group | The control group included 41 people (31 women and 10 men) with normal weight (BMI=18.5-24.9 kg/m2). Receives: Genetic: MT-ATP6 mtDNA gene variability in obesity and normal body weight patients.; Genetic: SCD gene variability in obesity and normal body weight patients.; Other: Finding TOFI and FOTI phenotypes in participants with obesity and normal weight. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCD variability between study and control group.
Variability between groups will be determined based on the SCD gene sequence.
Measured: 1 day
MT-ATP6 gene variability.
Variability between groups will be determined based on the MT-ATP6 gene sequence.
Measured: 1 day
Numbers of TOFI and FOTI phenotypes.
On the basis of the VAT/SAT ratio, the abdominal adipose tissue phenotype will assessed.
Measured: 1 day
Genetic variability between TOFI and FOTI phenotypes.
Genetic variability between TOFI and FOTY phenotypes will be determined based on the SCD and MT-ATP6 genes.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start10 Apr 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, VisceralStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damian D Pogodziński, Master, Study chair, Medical University of Białystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789888
- Sponsor's protocol ID
- SUB/3/DN/22/001/3316
- Status last verified
- Feb 2023
- First submitted
- 8 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants were coded and their IPD will not shared to other reasearchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of SNP Variability of Stearoyl-CoA Desaturase (SCD) Gene of Nuclear DNA and MT-ATP6 Gene of Mitochondrial DNA and Environmental Factors on Phenotypic Variability of Visceral and Subcutaneous Adipose Tissue
- ClinicalTrials.gov ID
- NCT05789888
- Acronym / sponsor ID
- SUB/3/DN/22/001/3316
- Conditions
- Obesity, Visceral, Obesity
- Keywords
- SCD, MT-ATP6, Obesity, VAT, SAT, TOFI, FOTI, Genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 29 Mar 2023 (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 goal of this clinical trial is to learn about variability of gene SCD and MT-ATP6 in describe participant population and health conditions. The main questions it aims to answer are:
- whether there is variation in genes between obese and normal weight individuals
Participants will get body weight and high was assessed using the medical scale and stadiometer, then, basis on obtained results, the Body Mass Index (BMI) will be calculated. Next, participants get determine the body composition and body composition analysis by bioelectrical impedance method to determined: Visceral Adipose Tissue (VAT in cm2 and %), Subcutaneous Adipose Tissue (SAT in cm2 and %), and the VAT/SAT ratio was also determined. Then order to examine the sequence of the genes, swab will take from the oral cavity (cheeks and palate) using sterile swab. The research was carried out at the Department of Dietetics and Clinical Nutrition (Medical University of Bialystok).
Detailed description
The approved of the Bioethics Committee of the Medical University, No. APK.002.407.2020, was obtained for the study. 116 people meeting the inclusion criteria were included in the intervention and observational study. The research was carried out at the Department of Dietetics and Clinical Nutrition at the Faculty of Health Sciences of the Medical University of Bialystok.
The study took place from the April to the September 2021. The analysis were performed in the morning, fasting, without intensive physical ac-tivity. Body weight and high was assessed using the medical scale and stadiometer with an accuracy of 0.01 kg for the body weight and 0.5 cm for the body high. Then, basis on obtained results, the Body Mass Index (BMI) was calculated.Basis on the obtained results the participants were divided into the study group (n=75) and control group (n=41). The study group consisted 46 women and 29 men with primary obesity (BMI=30.0-39.9 kg/m2). The control group consisted 31 women and 10 men with normal body weight (BMI=18.5-24.9 kg/m2).
In order to determine the body composition of participants, a body composition analysis by bioelectrical impedance method was conducted, which enabled the assessment of the following parameters: total body fat mass (kg), total percentage of body fat (%), total percentage of free fat mass (%). The area of adipose tissue in the transverse section to the abdomen was also deter-mined: Visceral Adipose Tissue (VAT in cm2 and %), Subcutaneous Adipose Tissue (SAT in cm2 and %), and the VAT/SAT ratio was also determined. To determine the TOFI phenotype of abdominal fat distribution VAT/SAT ratio was used- above 1 for men and above 0.9 for women.
Next swab from the oral cavity was took. To isolate DNA from the swabs, was used ready kit from A\&A Biotechnology. After it we did the PCR reactions with the appropriate primers and clean up after PCR reaction was did. Next we prepared the samples for Sanger sequencing.
When we get the sequences, we used the genetics programs: Bioedit, Chromas, DnaSP, Arlequin, Mega, Genepop to get number of haplotypes, genes variability, F statistics, haplotype diversity, haplotypes network and genetic tree of haplotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Genetic: MT-ATP6 mtDNA gene variability in obesity and normal body weight patients., Genetic: SCD gene variability in obesity and normal body weight patients., Other: Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.The study group consisted of 75 people (46 women and 29 men) with gender (BMI=30.0-39.9 kg/m2). |
| Control group | – | Genetic: MT-ATP6 mtDNA gene variability in obesity and normal body weight patients., Genetic: SCD gene variability in obesity and normal body weight patients., Other: Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.The control group included 41 people (31 women and 10 men) with normal weight (BMI=18.5-24.9 kg/m2). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Inhabitants of the Podlaskie Voivodeship.
Key inclusion criteria (1 listed)
- primary obesity and normal body weight
Key exclusion criteria (11 listed)
- absence of inflammation and periodontal disease in the oral cavity
- secondary obesity
- type 1 diabetes
- type 2 diabetes
- endocrine disorders
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 |
|---|---|---|
| MT-ATP6 mtDNA gene variability in obesity and normal body weight patients.Also: The search for obesity markersAs part of the research, the MT-ATP6 gene was tested in order to influence the modulation of the amount of fat contained. | Genetic | Control group, Study group |
| SCD gene variability in obesity and normal body weight patients.Also: The search for obesity markersAs part of the research, the SCD gene was tested in order to influence the modulation of the amount of fat contained. | Genetic | Control group, Study group |
| Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.Also: Phenotypes in obesityAs part of the research, we measured the amount of VAT and SAT and calculate VAT/SAT ratio as a marker to determine the phenotype of fat tissue. | Other | Control group, Study group |
Primary outcome
SCD variability between study and control group.
Time frame: 1 day
Variability between groups will be determined based on the SCD gene sequence.
MT-ATP6 gene variability.
Time frame: 1 day
Variability between groups will be determined based on the MT-ATP6 gene sequence.
Numbers of TOFI and FOTI phenotypes.
Time frame: 1 day
On the basis of the VAT/SAT ratio, the abdominal adipose tissue phenotype will assessed.
Genetic variability between TOFI and FOTI phenotypes.
Time frame: 1 day
Genetic variability between TOFI and FOTY phenotypes will be determined based on the SCD and MT-ATP6 genes.
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 29 Mar 2023.
- Individual participant dataSharing planned: No. Participants were coded and their IPD will not shared to other reasearchers.
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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 D Pogodziński, Master study chair
Medical University of Białystok
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 Obesity, Visceral and Obesity, run by Medical University of Bialystok 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 1 inclusion and 11 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 29 Mar 2023. 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?
SCD variability between study and control group. (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.