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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318288
• Other study ID #: 2/2020
• Status: Completed
• Start date: January 7, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2020
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: December 20, 2019
• Est. primary completion date: November 30, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
Italy	National Institute of Gastroenterology IRCCS S. de Bellis	Castellana Grotte	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index	Body mass index (BMI) (expressed in kg/m^2)	baseline
Primary	waist circumference	waist circumference (WC) (expressed in cm)	baseline
Primary	neck circumference	neck circumference (NC) (expressed in cm)	baseline
Primary	waist to height ratio	waist to height ratio (WHtR)	baseline
Secondary	Intima-media thickness	Intima-media thickness (IMT) (expressed in mm)	baseline
Secondary	Blood pressure	blood pressure (BP) expressed in mmHg	baseline
Secondary	Total Cholesterol	Total Cholesterol (expressed in mg/dL) concentration in serum	baseline
Secondary	Triglyceride	Triglyceride (expressed in mg/dL) concentration in serum	baseline
Secondary	fasting blood glucose	fasting blood glucose (FBG) (expressed in mg/dL) concentration in serum	baseline
Secondary	HDL Cholesterol	HDL Cholesterol (expressed in mg/dL) concentration in serum	baseline
Secondary	Insulin	Insulin (expressed in mg/dL) concentration in serum	baseline
Secondary	Homeostasis model assessment: insulin resistance	Homeostasis model assessment: insulin resistance index (HOMA-IR)	baseline
Secondary	LDL Cholesterol	LDL Cholesterol (expressed in mg/dL) concentration in serum	baseline
Secondary	Platelets	Platelets (expressed in 10^3/µL) concentration in serum	baseline
Secondary	white blood cells	white blood cells (WBC) (expressed in 10^3/µL) concentration in serum	baseline
Secondary	Vitamin D	Vitamin D (expressed in ng/dL) concentration in serum	baseline
Secondary	C-reactive Protein	C-reactive Protein (CRP) (expressed in mg/dL)	baseline