Effects of Physical Training and Nutrition Education on Adipocytokines in Severely Obese Teenagers (OBAPA)

August 24, 2010 updated by: Centre Hospitalier Universitaire de Besancon
Obesity is now becoming significantly prevalent of an environment characterized by easily available calorics foods combined with sedentary lifestyles. Moreover, it has been demonstrated that obesity is associated with metabolic complications such as disturbed adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose of this study is to assess the effects of a lifestyle intervention focused on various physical activities and nutrition education on adipocytokines hormones, in severely obese teenagers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

32

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

  • France
      • Besançon, France, 25030
        • Centre Hospitalier Universitaire

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

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

obese teenagers

Description

Inclusion Criteria:

  • to be aged from 12 to 17
  • to have a body mass index > 97 percentile for age and gender

Exclusion criteria:

  • systemic disease
  • endocrine disorder
  • syndromic obesity
  • subjects receiving medication with a history of recent intercurrent illness

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adipocytokines (leptin, adiponectin, ghrelin, PAI-1, resistin), based on subject's arterialized capillary blood samples.
Time Frame: during a lifestyle intervention of 9 months
during a lifestyle intervention of 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight, body mass index, waist and hip circumference
Time Frame: during a lifestyle intervention of 9 months
during a lifestyle intervention of 9 months
Body composition, calculated by a multifrequency bioelectric impedance
Time Frame: during a lifestyle intervention of 9 months
during a lifestyle intervention of 9 months
Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis.
Time Frame: during a lifestyle intervention of 9 months
during a lifestyle intervention of 9 months
Insulin resistance, calculated according to the formula of homeostasis model assessment
Time Frame: during a lifestyle intervention of 9 months
during a lifestyle intervention of 9 months
Systolic and diastolic blood pressure, measured in millimeters of mercury at the level of the left brachial artery, using an automatic blood pressure monitor.
Time Frame: during a lifestyle intervention of 9 months
during a lifestyle intervention of 9 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Nhu Uyen Nguyen, MD, PhD, CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2007/64
  • 2007-A01319-44 (Other Identifier: French Health Products Savety Agency)

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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