Clinical trial NCT05810506: Non-Alcoholic Fatty Liver Disease and Anthropometric Measurements
Official title: Evaluation of Anthropometric Measurements and Biochemical Parameters in Non-Alcoholic Fatty Liver Patients and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: non-alcoholic fatty liver disease
anthropometric measurements
body shape index
body roundness index
visceral adiposity index
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 82
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals with non-alcoholic fatty liver disease

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: Six month
measure: Height
timeFrame: Six month
measure: Body fat percentage
timeFrame: Six month
measure: Neck circumference
timeFrame: Six month
measure: Waist circumference
timeFrame: Six month
measure: Hip circumference
timeFrame: Six month
measure: Body mass index
timeFrame: Six month
measure: Waist-to-length ratio
timeFrame: Six month
measure: Waist to hip ratio
timeFrame: Six month
measure: Body shape index
timeFrame: Six month
measure: Body roundness index
timeFrame: Six month
measure: Visceral adiposity index
timeFrame: Six month
Secondary outcomes:
Other outcomes:
Locations:
city: Bandırma
country: Turkey
facility: Bandırma onyedi eylül unıversıty
state: Balıkesir
Study officials:
References: