- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05810506
Non-Alcoholic Fatty Liver Disease and Anthropometric Measurements
Evaluation of Anthropometric Measurements and Biochemical Parameters in Non-Alcoholic Fatty Liver Patients and Healthy Individuals
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Balıkesir
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Bandırma, Balıkesir, Turkey
- Bandırma onyedi eylül unıversıty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tuba ONAY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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