Comparison of Body Mass Index and Metabolic Score for Visceral Adiposity in Evaluation of Visceral Adiposity

Visceral Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05648409
• Other study ID #: METSVF-adiposity
• Status: Completed
• Start date: January 10, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2022
• Source: Goztepe Prof Dr Suleyman Yalcin City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Obesity
• Obesity, Abdominal
• Visceral Obesity

Locations

Country	Name	City	State
Turkey	Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Prof Dr Suleyman Yalcin City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year