Visceral ObesityNCT05648409
Comparison of Body Mass Index and Metabolic Score for Visceral Adiposity in Evaluation of Visceral Adiposity
An observational study of Visceral Obesity, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Visceral obesity is a major risk factor for cardiometabolic diseases such as type 2 diabetes, hypertension, and coronary artery disease. In clinical settings and during research, "body mass index (BMI)" is usually used for assessing obesity, and when it is above 30 kg/m2, it is defined as obesity. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Obesity
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2022to 1 Nov 2022
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients aged between 20 and 50 years old who underwent abdominal computed tomography (CT) imaging, including the L3-L4 level for any reason in the last month, with no detectable malignancy, pancreatitis, diseases requiring further investigation, chronic inflammatory diseases, and a pathology necessitating hospitalization for more than 24 hours in the CT evaluation, we're invited to the study.
Who may be able to join
- Having consented to the work
- Having a computed tomography of the abdomen taken within the last month
- Having a biochemistry analysis including lipid levels in the last three months
- No weight loss in the last 3 months
Who cannot join
- Antihyperlipidemic medication usage
- Presence of active malignancy
- Having an anatomical structure that is not suitable for taking anthropometric measurements
- The use medications that might affect metabolic values such as steroids
- Chronic inflammatory diseases, acute infection and other lipodystrophic syndromes (HIV etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: Comparison of the Body Mass Index, Visceral Adiposity Index, the Body Shape Index, and the Body Roundness Index With the Metabolic Score for Visceral Adiposity in the Assessment of Visceral Adiposity
Visceral obesity is a major risk factor for cardiometabolic diseases such as type 2 diabetes, hypertension, and coronary artery disease. In clinical settings and during research, "body mass index (BMI)" is usually used for assessing obesity, and when it is above 30 kg/m2, it is defined as obesity. However, the risk posed by obesity is more related to body fat distribution than total body fat, and BMI only reflects the second. Individuals with a BMI below 30, even 25, may still have visceral adiposity detectable via an abdominal computerized tomography ( CT) or magnetic resonance imaging (MRI). Therefore new, practical, inexpensive parameters are needed to evaluate visceral adiposity. "Metabolic Score for Visceral Adiposity (METS-VF)", "Body Shape Index (BSI)", "Conicity Index (CI)" and "Body Roundness Index (BRI)" are a few recent indexes developed trying to fulfill these needs. The aim is to investigate the effectivity of METS-VF in comparison with BMI, BSI, CI, and BRI in reflecting visceral adiposity assessed with CT.
Read the detailed description
This study is a single-center, observational and prospective study. Patients who underwent abdominal computed tomography (CT) covering the L3-L4 level in the last month for any reason and who did not have any of the following situations in the participants' CT reports: malignancy, pancreatitis, diseases requiring further investigation, chronic inflammatory diseases, and a pathology requiring hospitalization for more than 24 hours, will be invited to the study. Of the patients who consent to the study, gender, age, education level, current diseases, medications, and smoking status are questioned. Anthropometric measurements, especially waist, height, and weight are taken. Patients' biochemical parameters such as lipid profiles (LDL-cholesterol, HDL-cholesterol, Triglyceride), urea, creatinine, uric acid, fasting blood glucose, and C-peptide levels (after 8-12 hours of fasting), and thyroid hormones were measured in the last three months are recorded from the participants' files. The body mass index (BMI) of the patients will be calculated with the formula weight (kg) / height (m)2. Patients will be in 5 groups with BMI <25 kg/m2, 25-29.9 kg/m2, 30-34.9 kg/m2, 35-39.9 kg/m2, and >40 kg/m2, with 40 patients in each group. Visceral adipose tissue will be calculated by the radiologist by measuring with the "slicer" method at the level of L3-4 on abdominal CT. For "Metabolic Score for Visceral Fat (METS-VF)", the formula 4.466 + 0.011*(Ln(METS-IR))3 + 3.239*(Ln(Waist/height ratio))3 + 0.319*(Gender) + 0.594*(Ln(Age)) and for "Body Waist Circumference" the formula (BMI2/3 * height1/2) are used. Based on the visceral adipose tissue measured by CT, firstly, BMI and METS-VF will be compared, and then the other mentioned anthropometric index values will be compared statistically. The assumption is that the METS-VF index is superior to the other indexes, including the BMI. Also, as a second endpoint, it is aimed to find a cut-off value for METS-VF in Turkish individuals to reflect the increased visceral adiposity assessed with CT.
- Conditions
- Visceral Obesity
- Keywords
- visceral adiposity, metabolic score for visceral fat (METS-VF), body mass index
- Medical subject headings
- Obesity, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Body Mass Index (BMI) for visceral adiposity
The study aims to evaluate the effectiveness of the Metabolic Score for Visceral Fat (METS-VF) on the evaluation of visceral adiposity compared with the Body Mass Index (BMI). For METS-VF, a cut-off value will be determined. For BMI values 20-24.9 are accepted as normal, 25-29.9 as overweight and above 30 as obese (with different categories), whereas below 20 as underweight.
Measured: through study completion, an average of 1 year
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Visceral Adiposity Index (VAI) for visceral adiposity
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and Visceral Adiposity Index (VAI) for which higher values are predicted to reflect higher adiposity.
Measured: through study completion, an average of 1 year
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Body Shape Index (ABSI) for visceral adiposity
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and the Body Shape Index (ABSI) for which higher values are predicted to reflect higher adiposity.
Measured: through study completion, an average of 1 year
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Body Roundness Index (BRI) for visceral adiposity
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and the Body Roundness Index (BRI) for which higher values are predicted to reflect higher adiposity.
Measured: through study completion, an average of 1 year
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the evaluation of visceral adiposity
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and the other defined indexes, the Body Mass Index (BMI), Visceral Adiposity Index (VAI), the Body Shape Index (ABSI), and the Body Roundness Index (BRI) with the purpose of finding the best discriminator for visceral adiposity.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Determination of a cut-off point for METS-VF score associated with increased Visceral Adiposity
Using receiver-operating characteristics (ROC) curve analysis with the calculated input from the abdominal computerized tomography and the Metabolic Score for Visceral Fat (METS-VF) index. METS-VF index is a continuous index with no definite cut-off value. For different populations a new cut-off point is calculated, which it is also aimed in this study. The higher the score, the higher is the expected visceral adiposity.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start10 Jan 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visceral ObesityStudies 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
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cundullah Torun, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Cundullah Torun, MD, Principal investigator, Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital, Egitim mah. Kadıköy/ İstanbul, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648409
- Sponsor's protocol ID
- METSVF-adiposity
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torun C, Ankarali H, Castur L, Uzunlulu M, Erbakan AN, Akbas MM, Gunduz N, Dogan MB, Oguz A. Is Metabolic Score for Visceral Fat (METS-VF) a Better Index Than Other Adiposity Indices for the Prediction of Visceral Adiposity. Diabetes Metab Syndr Obes. 2023 Aug 29;16:2605-2615. doi: 10.2147/DMSO.S421623. eCollection 2023.
PubMed 37663201
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Body Mass Index, Visceral Adiposity Index, the Body Shape Index, and the Body Roundness Index With the Metabolic Score for Visceral Adiposity in the Assessment of Visceral Adiposity
- ClinicalTrials.gov ID
- NCT05648409
- Acronym / sponsor ID
- METSVF-adiposity
- Conditions
- Visceral Obesity
- Keywords
- visceral adiposity, metabolic score for visceral fat (METS-VF), body mass index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 13 Dec 2022 (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.
Visceral obesity is a major risk factor for cardiometabolic diseases such as type 2 diabetes, hypertension, and coronary artery disease. In clinical settings and during research, "body mass index (BMI)" is usually used for assessing obesity, and when it is above 30 kg/m2, it is defined as obesity. However, the risk posed by obesity is more related to body fat distribution than total body fat, and BMI only reflects the second. Individuals with a BMI below 30, even 25, may still have visceral adiposity detectable via an abdominal computerized tomography ( CT) or magnetic resonance imaging (MRI). Therefore new, practical, inexpensive parameters are needed to evaluate visceral adiposity. "Metabolic Score for Visceral Adiposity (METS-VF)", "Body Shape Index (BSI)", "Conicity Index (CI)" and "Body Roundness Index (BRI)" are a few recent indexes developed trying to fulfill these needs. The aim is to investigate the effectivity of METS-VF in comparison with BMI, BSI, CI, and BRI in reflecting visceral adiposity assessed with CT.
Detailed description
This study is a single-center, observational and prospective study. Patients who underwent abdominal computed tomography (CT) covering the L3-L4 level in the last month for any reason and who did not have any of the following situations in the participants' CT reports: malignancy, pancreatitis, diseases requiring further investigation, chronic inflammatory diseases, and a pathology requiring hospitalization for more than 24 hours, will be invited to the study. Of the patients who consent to the study, gender, age, education level, current diseases, medications, and smoking status are questioned. Anthropometric measurements, especially waist, height, and weight are taken. Patients' biochemical parameters such as lipid profiles (LDL-cholesterol, HDL-cholesterol, Triglyceride), urea, creatinine, uric acid, fasting blood glucose, and C-peptide levels (after 8-12 hours of fasting), and thyroid hormones were measured in the last three months are recorded from the participants' files. The body mass index (BMI) of the patients will be calculated with the formula weight (kg) / height (m)2. Patients will be in 5 groups with BMI <25 kg/m2, 25-29.9 kg/m2, 30-34.9 kg/m2, 35-39.9 kg/m2, and >40 kg/m2, with 40 patients in each group. Visceral adipose tissue will be calculated by the radiologist by measuring with the "slicer" method at the level of L3-4 on abdominal CT. For "Metabolic Score for Visceral Fat (METS-VF)", the formula 4.466 + 0.011*(Ln(METS-IR))3 + 3.239*(Ln(Waist/height ratio))3 + 0.319*(Gender) + 0.594*(Ln(Age)) and for "Body Waist Circumference" the formula (BMI2/3 * height1/2) are used. Based on the visceral adipose tissue measured by CT, firstly, BMI and METS-VF will be compared, and then the other mentioned anthropometric index values will be compared statistically. The assumption is that the METS-VF index is superior to the other indexes, including the BMI. Also, as a second endpoint, it is aimed to find a cut-off value for METS-VF in Turkish individuals to reflect the increased visceral adiposity assessed with CT.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged between 20 and 50 years old who underwent abdominal computed tomography (CT) imaging, including the L3-L4 level for any reason in the last month, with no detectable malignancy, pancreatitis, diseases requiring further investigation, chronic inflammatory diseases, and a pathology necessitating hospitalization for more than 24 hours in the CT evaluation, we're invited to the study.
Key inclusion criteria (4 listed)
- Having consented to the work
- Having a computed tomography of the abdomen taken within the last month
- Having a biochemistry analysis including lipid levels in the last three months
- No weight loss in the last 3 months
Key exclusion criteria (5 listed)
- Antihyperlipidemic medication usage
- Presence of active malignancy
- Having an anatomical structure that is not suitable for taking anthropometric measurements
- The use medications that might affect metabolic values such as steroids
- Chronic inflammatory diseases, acute infection and other lipodystrophic syndromes (HIV etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Body Mass Index (BMI) for visceral adiposity
Time frame: through study completion, an average of 1 year
The study aims to evaluate the effectiveness of the Metabolic Score for Visceral Fat (METS-VF) on the evaluation of visceral adiposity compared with the Body Mass Index (BMI). For METS-VF, a cut-off value will be determined. For BMI values 20-24.9 are accepted as normal, 25-29.9 as overweight and above 30 as obese (with different categories), whereas below 20 as underweight.
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Visceral Adiposity Index (VAI) for visceral adiposity
Time frame: through study completion, an average of 1 year
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and Visceral Adiposity Index (VAI) for which higher values are predicted to reflect higher adiposity.
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Body Shape Index (ABSI) for visceral adiposity
Time frame: through study completion, an average of 1 year
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and the Body Shape Index (ABSI) for which higher values are predicted to reflect higher adiposity.
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Body Roundness Index (BRI) for visceral adiposity
Time frame: through study completion, an average of 1 year
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and the Body Roundness Index (BRI) for which higher values are predicted to reflect higher adiposity.
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the evaluation of visceral adiposity
Time frame: through study completion, an average of 1 year
The number of participants whose visceral adiposity, which was evaluated by abdominal computerized tomography, was correctly assessed by using the Metabolic Score for Visceral Fat (METS-VF) and the other defined indexes, the Body Mass Index (BMI), Visceral Adiposity Index (VAI), the Body Shape Index (ABSI), and the Body Roundness Index (BRI) with the purpose of finding the best discriminator for visceral adiposity.
1 secondary outcome
Determination of a cut-off point for METS-VF score associated with increased Visceral Adiposity
Time frame: through study completion, an average of 1 year
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 20 Dec 2022.
- Derived from this study: PubMed 37663201Torun C, Ankarali H, Castur L, Uzunlulu M, Erbakan AN, Akbas MM, Gunduz N, Dogan MB, Oguz A. Is Metabolic Score for Visceral Fat (METS-VF) a Better Index Than Other Adiposity Indices for the Prediction of Visceral Adiposity. Diabetes Metab Syndr Obes. 2023 Aug 29;16:2605-2615. doi: 10.2147/DMSO.S421623. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Cundullah Torun, MD principal investigator
Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital, Egitim mah. Kadıköy/ İstanbul, TURKEY
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 Visceral Obesity, run by Goztepe Prof Dr Suleyman Yalcın City Hospital 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 4 inclusion and 5 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 20 Dec 2022. 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?
The Superiority of the Metabolic Score for Visceral Fat (METS-VF) on the Body Mass Index (BMI) for visceral adiposity (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648409, which also lists 1 linked publication.
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 20 Dec 2022.