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Completed

NCT Number: NCT04318288

Comparison of Anthropometric Parameters and Cardiometabolic Risk Factors Among Subjects With Overweight and Obesity

The study was aimed at comparing four different anthropometric parameters to cardiometabolic risk factors in overweight and obese subjects (Body Mass Index (BMI)≥25)

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70013, Italy

About this study

the present study was focused to compare the level of statistical association among four different anthropometric parameters, body mass index (BMI), waist circumference (WC), waist to height ratio (WHtR) and neck circumference (NC) and the cardiovascular (CV) risk factors most commonly evaluated in the clinical practice such as systolic and diastolic blood pressure, and fasting glucose, lipid (triglycerides, total, High-density lipoprotein (HDL) and Low-density lipoprotein (LDL) cholesterol), insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), uric acid, 25-hydroxyvitamin D (25(OH)D), c-reactive protein (CRP), white blood cells and platelet number in a population of 1214 apparently healthy subjects with overweight and obesity subjects

Who can participate

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

Inclusion criteria

  • Overweight or obesity (BMI> 25 Kg/m2)

Exclusion criteria

  • Any kind of drug
  • Hypertension
  • Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
  • Chronic inflammatory diseases
  • Renal failure
  • Liver failure
  • Angina pectoris
  • Myocardial infarction and heart failure
  • Genetic heart diseases
  • Thrombocytopenias

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. Body mass index

    Time frame: baseline

    Body mass index (BMI) (expressed in kg/m^2)

  2. waist circumference

    Time frame: baseline

    waist circumference (WC) (expressed in cm)

  3. neck circumference

    Time frame: baseline

    neck circumference (NC) (expressed in cm)

  4. waist to height ratio

    Time frame: baseline

    waist to height ratio (WHtR)

Secondary outcomes

  1. Intima-media thickness

    Time frame: baseline

    Intima-media thickness (IMT) (expressed in mm)

  2. Blood pressure

    Time frame: baseline

    blood pressure (BP) expressed in mmHg

  3. Total Cholesterol

    Time frame: baseline

    Total Cholesterol (expressed in mg/dL) concentration in serum

  4. Triglyceride

    Time frame: baseline

    Triglyceride (expressed in mg/dL) concentration in serum

  5. fasting blood glucose

    Time frame: baseline

    fasting blood glucose (FBG) (expressed in mg/dL) concentration in serum

  6. HDL Cholesterol

    Time frame: baseline

    HDL Cholesterol (expressed in mg/dL) concentration in serum

  7. Insulin

    Time frame: baseline

    Insulin (expressed in mg/dL) concentration in serum

  8. Homeostasis model assessment: insulin resistance

    Time frame: baseline

    Homeostasis model assessment: insulin resistance index (HOMA-IR)

  9. LDL Cholesterol

    Time frame: baseline

    LDL Cholesterol (expressed in mg/dL) concentration in serum

  10. Platelets

    Time frame: baseline

    Platelets (expressed in 10^3/µL) concentration in serum

  11. white blood cells

    Time frame: baseline

    white blood cells (WBC) (expressed in 10^3/µL) concentration in serum

  12. Vitamin D

    Time frame: baseline

    Vitamin D (expressed in ng/dL) concentration in serum

  13. C-reactive Protein

    Time frame: baseline

    C-reactive Protein (CRP) (expressed in mg/dL)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Official study title

Comparison of Different Anthropometric Parameters in Relation to Cardiometabolic Risk Factors in a Cohort of Subjects With Overweight and Obesity

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2020
Registry last updated
Mar 24, 2020

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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