Clinical trial NCT05789888: Genes Variability in Obesity and Normal Body Weight Patients.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Visceral
Obesity
Keywords: SCD
MT-ATP6
Obesity
VAT
SAT
TOFI
FOTI
Genetic
Genes
Phenotype
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhabitants of the Podlaskie Voivodeship.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: SCD variability between study and control group.
timeFrame: 1 day
measure: MT-ATP6 gene variability.
timeFrame: 1 day
measure: Numbers of TOFI and FOTI phenotypes.
timeFrame: 1 day
measure: Genetic variability between TOFI and FOTI phenotypes.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University of Bialystok
state: Podlaskie
Study officials:
affiliation: Medical University of Białystok
name: Damian D Pogodziński, Master
role: STUDY_CHAIR
References: