NCT05648409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

November 15, 2022

Last Update Submit

December 18, 2022

Conditions

Keywords

visceral adipositymetabolic score for visceral fat (METS-VF)body mass index

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Determination of a cut-off point for METS-VF score associated with increased Visceral Adiposity

    through study completion, an average of 1 year

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cundullah Torun, MD

    Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital, Egitim mah. Kadıköy/ İstanbul, TURKEY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2022

First Posted

December 13, 2022

Study Start

January 10, 2022

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations