NCT05789888

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
Last Updated

March 29, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

March 8, 2023

Last Update Submit

March 27, 2023

Conditions

Keywords

SCDMT-ATP6ObesityVATSATTOFIFOTIGeneticGenesPhenotype

Outcome Measures

Primary Outcomes (4)

  • SCD variability between study and control group.

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

    1 day

  • MT-ATP6 gene variability.

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

    1 day

  • Numbers of TOFI and FOTI phenotypes.

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

    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.

    1 day

Study Arms (2)

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.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).

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.

Interventions

As part of the research, the MT-ATP6 gene was tested in order to influence the modulation of the amount of fat contained.

Also known as: The search for obesity markers
Control groupStudy group

As part of the research, the SCD gene was tested in order to influence the modulation of the amount of fat contained.

Also known as: The search for obesity markers
Control groupStudy group

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.

Also known as: Phenotypes in obesity
Control groupStudy group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inhabitants of the Podlaskie Voivodeship.

You may qualify if:

  • primary obesity and normal body weight

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-089, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Swabs from mouth.

MeSH Terms

Conditions

Obesity, AbdominalObesity

Interventions

AdiposityPhenotype

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological PhenomenaGenetic Phenomena

Study Officials

  • Damian D Pogodziński, Master

    Medical University of Białystok

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 29, 2023

Study Start

April 10, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

March 29, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

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

Locations