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

Comparison of Different Anthropometric Parameters in Relation to Cardiometabolic Risk Factors in a Cohort of 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)

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Observational

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

• Study Type: Observational
• Enrollment (Actual): 1214

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Body mass index (BMI) (expressed in kg/m^2)	baseline
waist circumference	waist circumference (WC) (expressed in cm)	baseline
neck circumference	neck circumference (NC) (expressed in cm)	baseline
waist to height ratio	waist to height ratio (WHtR)	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intima-media thickness	Intima-media thickness (IMT) (expressed in mm)	baseline
Blood pressure	blood pressure (BP) expressed in mmHg	baseline
Total Cholesterol	Total Cholesterol (expressed in mg/dL) concentration in serum	baseline
Triglyceride	Triglyceride (expressed in mg/dL) concentration in serum	baseline
fasting blood glucose	fasting blood glucose (FBG) (expressed in mg/dL) concentration in serum	baseline
HDL Cholesterol	HDL Cholesterol (expressed in mg/dL) concentration in serum	baseline
Insulin	Insulin (expressed in mg/dL) concentration in serum	baseline
Homeostasis model assessment: insulin resistance	Homeostasis model assessment: insulin resistance index (HOMA-IR)	baseline
LDL Cholesterol	LDL Cholesterol (expressed in mg/dL) concentration in serum	baseline
Platelets	Platelets (expressed in 10^3/µL) concentration in serum	baseline
white blood cells	white blood cells (WBC) (expressed in 10^3/µL) concentration in serum	baseline
Vitamin D	Vitamin D (expressed in ng/dL) concentration in serum	baseline
C-reactive Protein	C-reactive Protein (CRP) (expressed in mg/dL)	baseline

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 21, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 2/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No