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临床试验/NCT05789888
NCT05789888已完成不适用

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

Medical University of Bialystok1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
SCD variability between study and control group.

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • primary obesity and normal body weight

排除标准

  • 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

结局指标

主要结局

SCD variability between study and control group.

时间窗: 1 day

Variability between groups will be determined based on the SCD gene sequence.

MT-ATP6 gene variability.

时间窗: 1 day

Variability between groups will be determined based on the MT-ATP6 gene sequence.

Genetic variability between TOFI and FOTI phenotypes.

时间窗: 1 day

Genetic variability between TOFI and FOTY phenotypes will be determined based on the SCD and MT-ATP6 genes.

Numbers of TOFI and FOTI phenotypes.

时间窗: 1 day

On the basis of the VAT/SAT ratio, the abdominal adipose tissue phenotype will assessed.

次要结局

未报告次要终点

研究者

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Sponsor

研究点 (1)

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