New Biomarkers for Predicting Systemic Complications in Obesity

NCT07260487 | Completed

• 1 other identifier: 24-KAEK-008
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Obesity

Keywords

metabolic syndrome; obesity; anthropometric indices; biochemical indices; cardiometabolic risk

Outcome Measures

Primary Outcomes (12)

• Body Mass Index (BMI) was used to classify levels of obesity.

  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.

  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

  Waist Circumference (cm) / Height (cm)

  Directly taken by trained staff during face-to-face assessments.

• Waist-to-Hip Ratio

  Waist Circumference (cm) / Hip Circumference (cm)

  Directly taken by trained staff during face-to-face assessments.

• Lipid Accumulation Product

  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

  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

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

  Directly taken by trained staff during face-to-face assessments.

• Body Adiposity Index

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

  Directly taken by trained staff during face-to-face assessments.

• Atherogenic Coefficient

  (Total Cholesterol - HDLc) / HDLc

  Biochemical data were retrospectively obtained from hospital medical records.

• Atherogenic Index of Plasma

  log10 (TG / HDLc)

  Biochemical data were retrospectively obtained from hospital medical records.

• TG/HDLc multiplied by Waist-to-Height Ratio combine index

  (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

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

  Biochemical data were retrospectively obtained from hospital medical records.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpaşa University Health Research and Application Hospital

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Elif A Özşahin Delibaş, Asst. Prof.

  Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Nutrition and Dietetics

  PRINCIPAL INVESTIGATOR

• Emre Y Kuyucu, Lecturer

  Tokat Gaziosmanpaşa Üniversity, Faculty of Medicine, Department of Biostatistics

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: January 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)