New Biomarkers for Predicting Systemic Complications in Obesity

November 21, 2025 updated by: Elif Azize Özşahin Delibaş, Tokat Gaziosmanpasa University

Assessment of Anthropometric and Biochemical Indices in Predicting Metabolic Syndrome Across Obesity Classes

This observational cross-sectional study classified participants into obesity classes (Class I: BMI 30.0-34.9, Class II: 35.0-39.9, Class III: ≥40.0 kg/m²) based on WHO criteria. Anthropometric and biochemical measurements were used to calculate a wide range of obesity-related and cardiometabolic risk indices. The aim was to analyze whether these indices could effectively predict the presence of Metabolic Syndrome (MetS), as defined by the NCEP-ATP III criteria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

In this study, a comprehensive set of anthropometric, biochemical, and derived indices was utilized to assess the relationship between obesity and Metabolic Syndrome (MetS) beyond the scope of traditional measures. While Body Mass Index (BMI) served as the primary criterion for general obesity classification, it was complemented by additional indices that are considered more reflective of fat distribution and visceral adiposity. These included the Visceral Adiposity Index (VAI), Waist-to-Height Ratio (WHtR), Waist-to-Hip Ratio (WHpR), Body Adiposity Index (BAI), and Conicity Index (COI), all of which provide greater specificity in evaluating central obesity-a key factor in cardiometabolic risk.

To capture the metabolic dimension of obesity, biochemical indices such as the Triglyceride-Glucose (TyG) index were calculated, as this marker has been shown to correlate strongly with early insulin resistance and glucose homeostasis disruption. Additionally, the Lipid Accumulation Product (LAP), which combines waist circumference and triglyceride levels, was employed to estimate the extent of visceral fat accumulation and its associated metabolic burden.

To further investigate cardiovascular and atherogenic risk, several lipid-based indices were assessed, including the Atherogenic Coefficient (AC), Atherogenic Plasma Index (API), the Triglyceride-to-HDL cholesterol (TG/HDL) ratio, non-HDL cholesterol, and the Cholindex. The inclusion of these diverse indices allowed for a more nuanced and multidimensional evaluation of the associations between obesity phenotypes and MetS status, with the aim of identifying reliable predictors beyond conventional clinical parameters.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
332

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

  • Turkey (Türkiye)
      • Tokat Province, Turkey (Türkiye), 60250
        • Tokat Gaziosmanpaşa University Health Research and Application Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Obese adult individuals (BMI ≥30 kg/m²) aged 18-65 years who presented voluntarily to an internal medicine outpatient clinic were included in the study. Participants had no known chronic diseases, were not pregnant or breastfeeding, and were not receiving hormone therapy or lipid-lowering treatment. Individuals with cardiovascular disease, thyroid dysfunction, polycystic ovary syndrome, malignancy, inflammatory disease, acute infection, or other metabolic disorders were excluded.

Description

Inclusion Criteria:

  • Being diagnosed with obesity
  • Being between the ages of 18 and 65

Exclusion Criteria:

  • Having any other chronic disease (cardiovascular disease, polycystic ovary syndrome, thyroid dysfunction, asthma, etc.)
  • Receiving hormone therapy
  • Taking lipid-lowering medication
  • Being pregnant/breastfeeding
  • Having an acute infection
  • Having a malignant or inflammatory disease

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI) was used to classify levels of obesity.
Time Frame: Directly taken by trained staff during face-to-face assessments.
BMI is an anthropometric parameter obtained by dividing body weight in kilograms by the square of height in metres (kg/m²). According to the World Health Organization (WHO) classification, individuals with a BMI of less than 18.5 kg/m² are underweight; those with a BMI between 18.5 and 24.9 kg/m² are of normal weight; those with a BMI between 25.0 and 29.9 kg/m² are overweight (pre-obese); and those with a BMI between 30.0 and 34.9 kg/m² are classified as class 1 obese (moderate); those between 35.0-39.9 kg/m² are class 2 obese (severe); and those ≥40.0 kg/m² are class 3 obese (morbid)
Directly taken by trained staff during face-to-face assessments.
MetS was diagnosed according to National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATP III) criteria.
Time Frame: Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
Five clinical parameters were evaluated accordingly: WC, FBG, HDLc, TG level and blood pressure. The following were accepted as components of MetS: WC≥102 cm in men and ≥88 cm in women; TG level ≥150 mg/dL; HDLc level <40 mg/dL in men and <50 mg/dL in women; blood pressure ≥130/85 mmHg; and FBG level ≥100 mg/dL. Individuals were classified as MetS (+) if at least three of the five specified parameters met the diagnostic criteria and as MetS (-) if they did not.
Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
Waist-to-Height Ratio
Time Frame: Directly taken by trained staff during face-to-face assessments.
Waist Circumference (cm) / Height (cm)
Directly taken by trained staff during face-to-face assessments.
Waist-to-Hip Ratio
Time Frame: Directly taken by trained staff during face-to-face assessments.
Waist Circumference (cm) / Hip Circumference (cm)
Directly taken by trained staff during face-to-face assessments.
Lipid Accumulation Product
Time Frame: Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
For men: [WC (cm) - 65] × TG (mmol/L) For women: [WC (cm) - 58] × TG (mmol/L)
Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
Visceral Adiposity Index
Time Frame: Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
For men: [WC (cm) / (39.68 + (1.88 × BMI))] × (TG / 1.03) × (1.31 / HDLc) For women: [WC (cm) / (36.58 + (1.89 × BMI))] × (TG / 0.81) × (1.52 / HDLc)
Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
Conicity Index
Time Frame: Directly taken by trained staff during face-to-face assessments.
WC (m) / [0.109 × √(Weight (kg) / Height (m))]
Directly taken by trained staff during face-to-face assessments.
Body Adiposity Index
Time Frame: Directly taken by trained staff during face-to-face assessments.
(Hip Circumference (cm) / [Height (m)]¹·⁵) - 18
Directly taken by trained staff during face-to-face assessments.
Atherogenic Coefficient
Time Frame: Biochemical data were retrospectively obtained from hospital medical records.
(Total Cholesterol - HDLc) / HDLc
Biochemical data were retrospectively obtained from hospital medical records.
Atherogenic Index of Plasma
Time Frame: Biochemical data were retrospectively obtained from hospital medical records.
log10 (TG / HDLc)
Biochemical data were retrospectively obtained from hospital medical records.
TG/HDLc multiplied by Waist-to-Height Ratio combine index
Time Frame: Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
(TG / HDLc) × WhtR
Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
Triglyceride-Glucose Index
Time Frame: Biochemical data were retrospectively obtained from hospital medical records.
ln [TG (mg/dL) × Fasting Glucose (mg/dL) / 2]
Biochemical data were retrospectively obtained from hospital medical records.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elif A Özşahin Delibaş, Asst. Prof., Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Nutrition and Dietetics
  • Study Chair: Emre Y Kuyucu, Lecturer, Tokat Gaziosmanpaşa Üniversity, Faculty of Medicine, Department of Biostatistics

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-KAEK-008

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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