Non-Alcoholic Fatty Liver Disease and Anthropometric Measurements

April 11, 2023 updated by: Tuba ONAY, Bandırma Onyedi Eylül University

Evaluation of Anthropometric Measurements and Biochemical Parameters in Non-Alcoholic Fatty Liver Patients and Healthy Individuals

The aim of this study; Which anthropometric measurement and ratio (BMI, waist circumference, hip circumference, waist-to-hip ratio, neck circumference, waist-height ratio, body shape index, body roundness index, visceral adiposity index) is a better indicator in healthy individuals with NAFLD and their biochemical parameters is to evaluate.

Study Overview

Detailed Description

NAFLD patients included in the study should sign a voluntary consent form, do not consume alcohol, be between 30-64 years old, have been diagnosed with NAFLD by applying to the gastroenterology outpatient clinic, have no other diseases, and should not use medication. Healthy individuals; they were required to sign the voluntary consent form, not consume alcohol, be between 30-64 years old, and not have any acute or chronic diseases. Individuals outside these criteria were not included in the study. The reason for the 30-64 age limit for individuals with NAFLD in the study is that NAFLD is more common in this age group. The same criteria were also taken into account in healthy individuals to avoid differences between groups. Individuals who met the inclusion criteria of the study and accepted to participate in the study voluntarily were selected by random sampling method and the sample of the study was formed. For the study, research permission was obtained from Gülhane Training and Research Hospital and ethical approval of the study from Ankara University Ethics Committee (56786525-050.04.04/236883). Written and verbal consent was obtained from the patients before starting the study. The research was conducted in accordance with both the Declarations of Helsinki and Istanbul. Biochemical Parameters Fasting blood glucose, total cholesterol, triglyceride, HDL, VLDL, LDL, ALP, AST, ALT and GGT values of the individuals participating in the study were obtained from the files with the permission of the patients.

Anthropometric Measurements The data were collected using a questionnaire form and face-to-face interview method. In the study, individuals' body weight (kg), height (cm), waist circumference (cm), hip circumference (cm), neck circumference (cm) measurements were taken in accordance with the method, and these measurement values were used to measure BMI, waist-height ratio, waist-hip ratio, body composition (fat mass, muscle mass, etc.), body shape index, body roundness index, visceral adiposity index measurements were calculated. Body mass index was calculated by dividing the body weight by the square of the height. Other anthropometric measurements and ratios were calculated using appropriate formulas.

Study Type

Observational

Enrollment (Actual)

82

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

    • Balıkesir
      • Bandırma, Balıkesir, Turkey
        • Bandırma onyedi eylül unıversıty

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy individuals with non-alcoholic fatty liver disease

Description

Inclusion Criteria for NAFLD patients:

  • should sign a voluntary consent form
  • do not consume alcohol
  • be between 30-64 years old
  • have been diagnosed with NAFLD by applying to the gastroenterology outpatient clinic
  • have no other diseases
  • should not use medication

Inclusion Criteria for healthy individuals:

  • should sign a voluntary consent form
  • do not consume alcohol
  • be between 30-64 years old
  • not have any acute or chronic diseases

Exclusion Criteria for NAFLD patients:

  • consuming alcohol
  • not be between 30-64 years old
  • being pregnant or lactating
  • any surgery in the last 3 months
  • Not being diagnosed with NAFLD
  • Hepatitis B-C, Wilson's disease, autoimmune liver diseases, cancer, cirrhosis, inflammatory bowel diseases, celiac, diabetes, cystic fibrosis, hereditary diseases, irritable bowel syndrome, kidney diseases, AIDS-HIV etc. have a disease
  • using any medication other than fatty liver

Exclusion Criteria for healthy individuals:

  • consuming alcohol
  • any acute or chronic illness
  • being pregnant-lactating
  • using any medicine
  • not be between 30-64 years old

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
Healthy
Healthy individuals; they were required to sign the voluntary consent form, not consume alcohol, be between 30-64 years old, and not have any acute or chronic diseases. Individuals outside these criteria were not included in the study. In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.
In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.
NAFLD
NAFLD patients included in the study should sign a voluntary consent form, do not consume alcohol, be between 30-64 years old, have been diagnosed with NAFLD by applying to the gastroenterology outpatient clinic, have no other diseases, and should not use medication. In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.
In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Six month
Body weight measurements of the patients will be made by removing thick clothes and shoes, and by means of TANITA BC-418 MA brand Bioelectrical Impedance Analysis (BIA).
Six month
Height
Time Frame: Six month
The height of the patients will be measured with a stadiometer while the feet are together and the head is in the Frankford plane.
Six month
Body fat percentage
Time Frame: Six month
The body fat mass of individuals will be measured with the TANITA BC-418 MA BIA analyzer.
Six month
Neck circumference
Time Frame: Six month
Measure with a non-stretchable tape measure horizontally at the upper edge of the laryngeal prominence with the head upright and eyes facing forward.
Six month
Waist circumference
Time Frame: Six month
The patient's side will be passed to the side of the patient and the circumference passing through the middle point will be measured between the lowest point of the rib bone and the iliac crest.
Six month
Hip circumference
Time Frame: Six month
The largest circumference between the waist and knees will be measured by going to the side of the patient.
Six month
Body mass index
Time Frame: Six month
It will be calculated by dividing the body weight by the square of the height
Six month
Waist-to-length ratio
Time Frame: Six month
It is the ratio of waist circumference to height.
Six month
Waist to hip ratio
Time Frame: Six month
It is the ratio of waist circumference to hip circumference.
Six month
Body shape index
Time Frame: Six month
Body shape index of patients; with height, waist circumference and BMI values; It will be calculated using the formula [Waist circumference/ (BKİ )2/3* Height 1/2].
Six month
Body roundness index
Time Frame: Six month
The body roundness index of the patients will be calculated using the formula [364.2-365.5x√1-[(waist circumference/(2π))2/(0.5 x height)2].
Six month
Visceral adiposity index
Time Frame: Six month
Patients' visceral adiposity index for men: [Waist circumference/ 39.68 + (1.88 × [BMI])] × [(TG)/1.03] × (1.31/HDL); for women: will be calculated using the formulas [Waist circumference /36.58 + (1.89 × BMI)] × (TG/0.81) × (1.52/HDL).
Six month

Collaborators and Investigators

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

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)

October 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

March 17, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD sharing is not planned.

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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