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Completed

NCT Number: NCT07260487

New Biomarkers for Predicting Systemic Complications in Obesity

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokat Gaziosmanpaşa University Health Research and Application Hospital

Tokat Province, 60250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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.

  3. Waist-to-Height Ratio

    Time frame: Directly taken by trained staff during face-to-face assessments.

    Waist Circumference (cm) / Height (cm)

  4. Waist-to-Hip Ratio

    Time frame: Directly taken by trained staff during face-to-face assessments.

    Waist Circumference (cm) / Hip Circumference (cm)

  5. 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)

  6. 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)

  7. Conicity Index

    Time frame: Directly taken by trained staff during face-to-face assessments.

    WC (m) / [0.109 × √(Weight (kg) / Height (m))]

  8. Body Adiposity Index

    Time frame: Directly taken by trained staff during face-to-face assessments.

    (Hip Circumference (cm) / [Height (m)]¹·⁵) - 18

  9. Atherogenic Coefficient

    Time frame: Biochemical data were retrospectively obtained from hospital medical records.

    (Total Cholesterol - HDLc) / HDLc

  10. Atherogenic Index of Plasma

    Time frame: Biochemical data were retrospectively obtained from hospital medical records.

    log10 (TG / HDLc)

  11. 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

  12. Triglyceride-Glucose Index

    Time frame: Biochemical data were retrospectively obtained from hospital medical records.

    ln [TG (mg/dL) × Fasting Glucose (mg/dL) / 2]

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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