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

March 21, 2020 updated by: Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: baseline
Body mass index (BMI) (expressed in kg/m^2)
baseline
waist circumference
Time Frame: baseline
waist circumference (WC) (expressed in cm)
baseline
neck circumference
Time Frame: baseline
neck circumference (NC) (expressed in cm)
baseline
waist to height ratio
Time Frame: baseline
waist to height ratio (WHtR)
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intima-media thickness
Time Frame: baseline
Intima-media thickness (IMT) (expressed in mm)
baseline
Blood pressure
Time Frame: baseline
blood pressure (BP) expressed in mmHg
baseline
Total Cholesterol
Time Frame: baseline
Total Cholesterol (expressed in mg/dL) concentration in serum
baseline
Triglyceride
Time Frame: baseline
Triglyceride (expressed in mg/dL) concentration in serum
baseline
fasting blood glucose
Time Frame: baseline
fasting blood glucose (FBG) (expressed in mg/dL) concentration in serum
baseline
HDL Cholesterol
Time Frame: baseline
HDL Cholesterol (expressed in mg/dL) concentration in serum
baseline
Insulin
Time Frame: baseline
Insulin (expressed in mg/dL) concentration in serum
baseline
Homeostasis model assessment: insulin resistance
Time Frame: baseline
Homeostasis model assessment: insulin resistance index (HOMA-IR)
baseline
LDL Cholesterol
Time Frame: baseline
LDL Cholesterol (expressed in mg/dL) concentration in serum
baseline
Platelets
Time Frame: baseline
Platelets (expressed in 10^3/µL) concentration in serum
baseline
white blood cells
Time Frame: baseline
white blood cells (WBC) (expressed in 10^3/µL) concentration in serum
baseline
Vitamin D
Time Frame: baseline
Vitamin D (expressed in ng/dL) concentration in serum
baseline
C-reactive Protein
Time Frame: baseline
C-reactive Protein (CRP) (expressed in mg/dL)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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