- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07260487
New Biomarkers for Predicting Systemic Complications in Obesity
Assessment of Anthropometric and Biochemical Indices in Predicting Metabolic Syndrome Across Obesity Classes
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tokat Province, Turkey (Türkiye), 60250
- Tokat Gaziosmanpaşa University Health Research and Application Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Body Mass Index (BMI) was used to classify levels of obesity.
Time Frame: Directly taken by trained staff during face-to-face assessments.
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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.
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Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
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Waist-to-Height Ratio
Time Frame: Directly taken by trained staff during face-to-face assessments.
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Waist Circumference (cm) / Height (cm)
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Directly taken by trained staff during face-to-face assessments.
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Waist-to-Hip Ratio
Time Frame: Directly taken by trained staff during face-to-face assessments.
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Waist Circumference (cm) / Hip Circumference (cm)
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Directly taken by trained staff during face-to-face assessments.
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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.
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For men: [WC (cm) - 65] × TG (mmol/L) For women: [WC (cm) - 58] × TG (mmol/L)
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Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
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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.
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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)
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Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
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Conicity Index
Time Frame: Directly taken by trained staff during face-to-face assessments.
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WC (m) / [0.109 × √(Weight (kg) / Height (m))]
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Directly taken by trained staff during face-to-face assessments.
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Body Adiposity Index
Time Frame: Directly taken by trained staff during face-to-face assessments.
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(Hip Circumference (cm) / [Height (m)]¹·⁵) - 18
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Directly taken by trained staff during face-to-face assessments.
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Atherogenic Coefficient
Time Frame: Biochemical data were retrospectively obtained from hospital medical records.
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(Total Cholesterol - HDLc) / HDLc
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Biochemical data were retrospectively obtained from hospital medical records.
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Atherogenic Index of Plasma
Time Frame: Biochemical data were retrospectively obtained from hospital medical records.
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log10 (TG / HDLc)
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Biochemical data were retrospectively obtained from hospital medical records.
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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.
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(TG / HDLc) × WhtR
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Anthropometric measurements were directly taken by trained staff during face-to-face assessments. Biochemical data were retrospectively obtained from hospital medical records.
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Triglyceride-Glucose Index
Time Frame: Biochemical data were retrospectively obtained from hospital medical records.
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ln [TG (mg/dL) × Fasting Glucose (mg/dL) / 2]
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Biochemical data were retrospectively obtained from hospital medical records.
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-KAEK-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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