Genes Variability in Obesity and Normal Body Weight Patients.

March 27, 2023 updated by: Medical University of Bialystok

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-089
        • Medical University of Bialystok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inhabitants of the Podlaskie Voivodeship.

Description

Inclusion Criteria:

  • primary obesity and normal body weight

Exclusion Criteria:

  • absence of inflammation and periodontal disease in the oral cavity
  • secondary obesity
  • type 1 diabetes
  • type 2 diabetes
  • endocrine disorders
  • appetite disorders
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
The study group consisted of 75 people (46 women and 29 men) with gender (BMI=30.0-39.9 kg/m2).
Genetic: MT-ATP6 mtDNA gene variability in obesity and normal body weight patients.
As part of the research, the MT-ATP6 gene was tested in order to influence the modulation of the amount of fat contained.
Other Names:
  • The search for obesity markers
Genetic: SCD gene variability in obesity and normal body weight patients.
As part of the research, the SCD gene was tested in order to influence the modulation of the amount of fat contained.
Other Names:
  • The search for obesity markers
Other: Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.
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.
Other Names:
  • Phenotypes in obesity
Control group
The control group included 41 people (31 women and 10 men) with normal weight (BMI=18.5-24.9 kg/m2).
Genetic: MT-ATP6 mtDNA gene variability in obesity and normal body weight patients.
As part of the research, the MT-ATP6 gene was tested in order to influence the modulation of the amount of fat contained.
Other Names:
  • The search for obesity markers
Genetic: SCD gene variability in obesity and normal body weight patients.
As part of the research, the SCD gene was tested in order to influence the modulation of the amount of fat contained.
Other Names:
  • The search for obesity markers
Other: Finding TOFI and FOTI phenotypes in participants with obesity and normal weight.
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.
Other Names:
  • Phenotypes in obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCD variability between study and control group.
Time Frame: 1 day
Variability between groups will be determined based on the SCD gene sequence.
1 day
MT-ATP6 gene variability.
Time Frame: 1 day
Variability between groups will be determined based on the MT-ATP6 gene sequence.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Investigators

  • Study Chair: Damian D Pogodziński, Master, Medical University of Białystok

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUB/3/DN/22/001/3316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants were coded and their IPD will not shared to other reasearchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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