Metabolic SyndromeNCT07260487
New Biomarkers for Predicting Systemic Complications in Obesity
An observational study of Metabolic Syndrome and Obesity, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- How many people
- 332 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Being diagnosed with obesity
- Being between the ages of 18 and 65
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa University Health Research and Application Hospital
Tokat Province, 60250
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- metabolic syndrome, obesity, anthropometric indices, biochemical indices, cardiometabolic risk
- Medical subject headings
- Metabolic Syndrome, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: Directly taken by trained staff during face-to-face assessments.
Waist-to-Hip Ratio
Waist Circumference (cm) / Hip Circumference (cm)
Measured: 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)
Measured: 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)
Measured: 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))]
Measured: Directly taken by trained staff during face-to-face assessments.
Body Adiposity Index
(Hip Circumference (cm) / [Height (m)]¹·⁵) - 18
Measured: Directly taken by trained staff during face-to-face assessments.
Atherogenic Coefficient
(Total Cholesterol - HDLc) / HDLc
Measured: Biochemical data were retrospectively obtained from hospital medical records.
Atherogenic Index of Plasma
log10 (TG / HDLc)
Measured: Biochemical data were retrospectively obtained from hospital medical records.
TG/HDLc multiplied by Waist-to-Height Ratio combine index
(TG / HDLc) × WhtR
Measured: 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]
Measured: Biochemical data were retrospectively obtained from hospital medical records.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2025
- Primary completion30 May 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Azize Özşahin Delibaş, Tokat Gaziosmanpasa University
- Investigators
- Elif A Özşahin Delibaş, Asst. Prof., Principal investigator, Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Nutrition and DieteticsEmre Y Kuyucu, Lecturer, Study chair, Tokat Gaziosmanpaşa Üniversity, Faculty of Medicine, Department of Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260487
- Sponsor's protocol ID
- 24-KAEK-008
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anthropometric and Biochemical Indices in Predicting Metabolic Syndrome Across Obesity Classes
- ClinicalTrials.gov ID
- NCT07260487
- Acronym / sponsor ID
- 24-KAEK-008
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- metabolic syndrome, obesity, anthropometric indices, biochemical indices, cardiometabolic risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Being diagnosed with obesity
- Being between the ages of 18 and 65
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
Waist-to-Height Ratio
Time frame: Directly taken by trained staff during face-to-face assessments.
Waist Circumference (cm) / Height (cm)
Waist-to-Hip Ratio
Time frame: Directly taken by trained staff during face-to-face assessments.
Waist Circumference (cm) / Hip Circumference (cm)
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)
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)
Conicity Index
Time frame: Directly taken by trained staff during face-to-face assessments.
WC (m) / [0.109 × √(Weight (kg) / Height (m))]
Body Adiposity Index
Time frame: Directly taken by trained staff during face-to-face assessments.
(Hip Circumference (cm) / [Height (m)]¹·⁵) - 18
Atherogenic Coefficient
Time frame: Biochemical data were retrospectively obtained from hospital medical records.
(Total Cholesterol - HDLc) / HDLc
Atherogenic Index of Plasma
Time frame: Biochemical data were retrospectively obtained from hospital medical records.
log10 (TG / HDLc)
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
Triglyceride-Glucose Index
Time frame: Biochemical data were retrospectively obtained from hospital medical records.
ln [TG (mg/dL) × Fasting Glucose (mg/dL) / 2]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 2/3
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif A Özşahin Delibaş, Asst. Prof. principal investigator
Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Emre Y Kuyucu, Lecturer study chair
Tokat Gaziosmanpaşa Üniversity, Faculty of Medicine, Department of Biostatistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Obesity, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) was used to classify levels of obesity. (time frame: Directly taken by trained staff during face-to-face assessments.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.