NCT01806493

Brief Summary

The prevalence of individuals who are classified as overweight or obese is increasing all over the world and it represents a primary health concern due to the relationship between obesity and a number of diseases, disabilities, comorbidities, and mortality. The definition of obesity should consider not only the increase of body weight but more precisely the increase in body fat mass. However, body composition evaluation is rarely performed in overweight and obese subjects and the diagnosis is almost always achieved just considering body mass index (BMI). In fact, whereas BMI can be considered an important tool in epidemiological surveys, different papers stated the limitations of the use of BMI in single individuals. Aim: to assess the determinants of body composition in a population of overweight and obese subjects and to propose a different model of estimation of fat mass (FM) in these subjects when more reliable equipments for the evaluation of body composition are not available. Methods: in 103 overweight or obese subjects ( 74 women, aged 41.5±10 years, and 29 men, aged 43.8±8 years); a multidimensional evaluation was performed including the assessment of body composition using Dual Energy X-Ray Absorptiometry (DXA), anthropometry, bioimpedance analysis (BIA) and biochemical parameters (total cholesterol, triacylglycerol, HDL- and LDL- cholesterol, free fatty acids and glycerol, glucose, insulin, C-reactive protein, plasma acylated and unacetylated ghrelin, adiponectin and leptin serum levels).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

February 28, 2013

Last Update Submit

March 6, 2013

Conditions

Keywords

body compositionobesity

Outcome Measures

Primary Outcomes (1)

  • body composition

    The purpose of this study is to verify the determinants of body composition in a population of overweight and obese subjects and to propose a different model of estimation of FM of these subjects when reliable equipments for the evaluation of body composition are not available. Body composition will be measured through anthropometry (skinfold thickness), bioimpedance analysis and DXA.

    one month

Study Arms (1)

obese subjects

One hundred and three overweight or obese subjects were included in the study: 74 women (aged 41.5±10 years) and 29 men (aged 43.8±8 years);

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy males and females aged from 25 to 45 years, with a BMI greater than 25 kg/m2 and less than 35 kg/m2, were eligible for the study.

You may qualify if:

  • Healthy males and females aged from 25 to 45 years, with a BMI greater than 25 kg/m2 and less than 35 kg/m2, were eligible for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villa delle Querce Rehabilitation Institute

Nemi, Italy, 00040, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 7, 2013

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations