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CompletedNCT04318288Updated Mar 24, 2020

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

An observational study in Obesity, sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,214
Sex
All
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Study summary

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

Read the detailed description

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

02

Conditions studied

  • Obesity
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 1,214 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis is the lead sponsor of 54 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,214 participants (actual)
Patient registry
No

Interventions

  • OtherObservational

    Observational

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What researchers measure

Primary outcomes

  1. Body mass index

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

    Time frame: baseline

  2. waist circumference

    waist circumference (WC) (expressed in cm)

    Time frame: baseline

  3. neck circumference

    neck circumference (NC) (expressed in cm)

    Time frame: baseline

  4. waist to height ratio

    waist to height ratio (WHtR)

    Time frame: baseline

Secondary outcomes

  1. Intima-media thickness

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

    Time frame: baseline

  2. Blood pressure

    blood pressure (BP) expressed in mmHg

    Time frame: baseline

  3. Total Cholesterol

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

    Time frame: baseline

  4. Triglyceride

    Triglyceride (expressed in mg/dL) concentration in serum

    Time frame: baseline

  5. fasting blood glucose

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

    Time frame: baseline

  6. HDL Cholesterol

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

    Time frame: baseline

  7. Insulin

    Insulin (expressed in mg/dL) concentration in serum

    Time frame: baseline

  8. Homeostasis model assessment: insulin resistance

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

    Time frame: baseline

  9. LDL Cholesterol

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

    Time frame: baseline

  10. Platelets

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

    Time frame: baseline

  11. white blood cells

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

    Time frame: baseline

  12. Vitamin D

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

    Time frame: baseline

  13. C-reactive Protein

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

    Time frame: baseline

07

Study locations

1 site
  • National Institute of Gastroenterology IRCCS S. de Bellis
    Castellana Grotte, Bari 70013, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04318288
Lead sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Responsible party
Gianluigi Giannelli (Clinical Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis) — Principal investigator
First posted
Mar 23, 2020
Start date
Jan 7, 2019
Primary completion
Nov 30, 2019
Completion
Dec 20, 2019
Last update
Mar 24, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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