Non-Alcoholic Fatty Liver Disease and Anthropometric Measurements

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810506
• Other study ID #: Tuba ONAY
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: March 17, 2023

Study information

• Verified date: April 2023
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 17, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

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.

Locations

Country	Name	City	State
Turkey	Bandirma onyedi eylül university	Bandirma	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	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
Primary	Height	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
Primary	Body fat percentage	The body fat mass of individuals will be measured with the TANITA BC-418 MA BIA analyzer.	Six month
Primary	Neck circumference	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
Primary	Waist circumference	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
Primary	Hip circumference	The largest circumference between the waist and knees will be measured by going to the side of the patient.	Six month
Primary	Body mass index	It will be calculated by dividing the body weight by the square of the height	Six month
Primary	Waist-to-length ratio	It is the ratio of waist circumference to height.	Six month
Primary	Waist to hip ratio	It is the ratio of waist circumference to hip circumference.	Six month
Primary	Body shape index	Body shape index of patients; with height, waist circumference and BMI values; It will be calculated using the formula [Waist circumference/ (BKI )2/3* Height 1/2].	Six month
Primary	Body roundness index	The body roundness index of the patients will be calculated using the formula [364.2-365.5xv1-[(waist circumference/(2p))2/(0.5 x height)2].	Six month
Primary	Visceral adiposity index	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