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HealthyOBAPANCT01188642

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

An observational study of Healthy and Obesity, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Obesity
What is being tested?
obesity lifestyle intervention
How many people
32 participants
Where
1 siteFrance
Study dates
Mar 2009to Jun 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: obese teenagers

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Universitaire

    Besançon, 25030

Other trials in France

About this study

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.

Conditions
Healthy, Obesity
Being tested
obesity lifestyle intervention
Keywords
childhood obesity, adipocytokines, physical exercise, nutrition education
Medical subject headings
Obesity, Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • obesity lifestyle interventionBehavioural

    physical activity 5 times per week + nutrition education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adipocytokines (leptin, adiponectin, ghrelin, PAI-1, resistin), based on subject's arterialized capillary blood samples.

    Measured: during a lifestyle intervention of 9 months

Secondary outcomes (5)

  1. Body weight, body mass index, waist and hip circumference

    Measured: during a lifestyle intervention of 9 months

  2. Body composition, calculated by a multifrequency bioelectric impedance

    Measured: during a lifestyle intervention of 9 months

  3. Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis.

    Measured: during a lifestyle intervention of 9 months

  4. Insulin resistance, calculated according to the formula of homeostasis model assessment

    Measured: during a lifestyle intervention of 9 months

  5. Systolic and diastolic blood pressure, measured in millimeters of mercury at the level of the left brachial artery, using an automatic blood pressure monitor.

    Measured: during a lifestyle intervention of 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2010 (estimated)
  2. Study startMar 2009
  3. Primary completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
32 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT01188642
Sponsor's protocol ID
P/2007/64
Other IDs
2007-A01319-44
Acronym
OBAPA
Status last verified
Aug 2010
First submitted
17 Aug 2010
Last updated
25 Aug 2010
Results posted
No
Data monitoring committee
No

Publications

  • Gueugnon C, Mougin F, Simon-Rigaud ML, Regnard J, Negre V, Dumoulin G. Effects of an in-patient treatment program based on regular exercise and a balanced diet on high molecular weight adiponectin, resistin levels, and insulin resistance in adolescents with severe obesity. Appl Physiol Nutr Metab. 2012 Aug;37(4):672-9. doi: 10.1139/h2012-045. Epub 2012 May 11.

    PubMed 22574715

  • Gueugnon C, Mougin F, Nguyen NU, Bouhaddi M, Nicolet-Guenat M, Dumoulin G. Ghrelin and PYY levels in adolescents with severe obesity: effects of weight loss induced by long-term exercise training and modified food habits. Eur J Appl Physiol. 2012 May;112(5):1797-805. doi: 10.1007/s00421-011-2154-2. Epub 2011 Sep 11.

    PubMed 21909986

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Obesity, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adipocytokines (leptin, adiponectin, ghrelin, PAI-1, resistin), based on subject's arterialized capillary blood samples. (time frame: during a lifestyle intervention of 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01188642, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2010.

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