- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05648409
Comparison of Body Mass Index and Metabolic Score for Visceral Adiposity in Evaluation of Visceral Adiposity
December 18, 2022 updated by: Cundullah Torun, Goztepe Prof Dr Suleyman Yalcın City Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
194
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cundullah Torun, MD, Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital, Egitim mah. Kadıköy/ İstanbul, TURKEY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2022
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
November 15, 2022
First Submitted That Met QC Criteria
December 4, 2022
First Posted (Actual)
December 13, 2022
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 18, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METSVF-adiposity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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