Non-Alcoholic Fatty Liver Disease and Anthropometric Measurements

Sponsor
Bandırma Onyedi Eylül University (Other)
Overall Status
Completed
CT.gov ID
NCT05810506
Collaborator
(none)
82
1
17.5
4.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
82 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Anthropometric Measurements and Biochemical Parameters in Non-Alcoholic Fatty Liver Patients and Healthy Individuals
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
Mar 17, 2023

Arms and Interventions

Arm 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.

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Body weight [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 [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 [Six month]

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

  4. Neck circumference [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 [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 [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 [Six month]

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

  8. Waist-to-length ratio [Six month]

    It is the ratio of waist circumference to height.

  9. Waist to hip ratio [Six month]

    It is the ratio of waist circumference to hip circumference.

  10. Body shape index [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bandırma onyedi eylül unıversıty Bandırma Balıkesir Turkey

Sponsors and Collaborators

  • Bandırma Onyedi Eylül University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tuba ONAY, Research Assistant Doctor /Principal İnvestigator, Bandırma Onyedi Eylül University
ClinicalTrials.gov Identifier:
NCT05810506
Other Study ID Numbers:
  • Tuba ONAY
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tuba ONAY, Research Assistant Doctor /Principal İnvestigator, Bandırma Onyedi Eylül University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2023