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Completed

NCT Number: NCT05810506

Non-Alcoholic Fatty Liver Disease and Anthropometric Measurements

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

30 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandırma onyedi eylül unıversıty

Bandırma, Balıkesir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.

Other

In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.

Primary outcomes

  1. 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).

  2. 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.

  3. Body fat percentage

    Time frame: Six month

    The body fat mass of individuals will be measured with the TANITA BC-418 MA BIA analyzer.

  4. 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.

  5. 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.

  6. 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.

  7. Body mass index

    Time frame: Six month

    It will be calculated by dividing the body weight by the square of the height

  8. Waist-to-length ratio

    Time frame: Six month

    It is the ratio of waist circumference to height.

  9. Waist to hip ratio

    Time frame: Six month

    It is the ratio of waist circumference to hip circumference.

  10. 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].

  11. 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].

  12. 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).

Sponsors and collaborators

Lead sponsor

Bandırma Onyedi Eylül University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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