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

Completed

• Conditions: Obesity

• Registration Number: NCT04318288
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief 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)

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 Timeline

• Study Start: 2019-01-07
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-20
• Status Verified: 2020-03
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Last Update Submitted: 2020-03-21
• Study First Posted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1214

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neck circumference	baseline	neck circumference (NC) (expressed in cm)
waist circumference	baseline	waist circumference (WC) (expressed in cm)
Body mass index	baseline	Body mass index (BMI) (expressed in kg/m\^2)
waist to height ratio	baseline	waist to height ratio (WHtR)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Institute of Gastroenterology IRCCS S. de Bellis; 🇮🇹 Castellana Grotte, Bari, Italy