Non-Alcoholic Fatty Liver DiseaseNCT05810506
Non-Alcoholic Fatty Liver Disease and Anthropometric Measurements
An observational study of Non-Alcoholic Fatty Liver Disease, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 17 Mar 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals with non-alcoholic fatty liver disease
Who may be able to join
- 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
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- should sign a voluntary consent form
- do not consume alcohol
- be between 30-64 years old
- not have any acute or chronic diseases
Who cannot join
- 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
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- using any medication other than fatty liver
- consuming alcohol
- any acute or chronic illness
- being pregnant-lactating
- using any medicine
- not be between 30-64 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma onyedi eylül unıversıty
Bandırma, Balıkesir
About this study
Official title: Evaluation of Anthropometric Measurements and Biochemical Parameters in Non-Alcoholic Fatty Liver Patients and Healthy Individuals
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.
- Keywords
- non-alcoholic fatty liver disease, anthropometric measurements, body shape index, body roundness index, visceral adiposity index
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Six month
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.
Measured: Six month
Body fat percentage
The body fat mass of individuals will be measured with the TANITA BC-418 MA BIA analyzer.
Measured: Six month
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.
Measured: Six month
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.
Measured: Six month
Hip circumference
The largest circumference between the waist and knees will be measured by going to the side of the patient.
Measured: Six month
Body mass index
It will be calculated by dividing the body weight by the square of the height
Measured: Six month
Waist-to-length ratio
It is the ratio of waist circumference to height.
Measured: Six month
Waist to hip ratio
It is the ratio of waist circumference to hip circumference.
Measured: Six month
Body shape index
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].
Measured: Six month
Body roundness index
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].
Measured: Six month
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).
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Oct 2021
- Primary completion30 Apr 2022
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba ONAY, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810506
- Sponsor's protocol ID
- Tuba ONAY
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not planned.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anthropometric Measurements and Biochemical Parameters in Non-Alcoholic Fatty Liver Patients and Healthy Individuals
- ClinicalTrials.gov ID
- NCT05810506
- Acronym / sponsor ID
- Tuba ONAY
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- non-alcoholic fatty liver disease, anthropometric measurements, body shape index, body roundness index, visceral adiposity index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.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. |
| NAFLD | – | Other: In the study, biochemical parameters will be taken from the anthropometric measurements and files of the patients without any intervention.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. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals with non-alcoholic fatty liver disease
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy, NAFLD |
Primary outcome
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).
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.
Body fat percentage
Time frame: Six month
The body fat mass of individuals will be measured with the TANITA BC-418 MA BIA analyzer.
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.
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.
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.
Body mass index
Time frame: Six month
It will be calculated by dividing the body weight by the square of the height
Waist-to-length ratio
Time frame: Six month
It is the ratio of waist circumference to height.
Waist to hip ratio
Time frame: Six month
It is the ratio of waist circumference to hip circumference.
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].
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].
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No. IPD sharing is not planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Six month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.