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

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01188642
First received: August 17, 2010
Last updated: August 24, 2010
Last verified: August 2010

August 17, 2010
August 24, 2010
March 2009
June 2009   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01188642 on ClinicalTrials.gov Archive Site
  • Body weight, body mass index, waist and hip circumference [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • Body composition, calculated by a multifrequency bioelectric impedance [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis. [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • Insulin resistance, calculated according to the formula of homeostasis model assessment [ Time Frame: during a lifestyle intervention of 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
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Effects of Physical Training and Nutrition Education on Adipocytokines in Severely Obese Teenagers
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

obese teenagers

  • Healthy
  • Obesity
Behavioral: obesity lifestyle intervention
physical activity 5 times per week + nutrition education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
June 2009   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01188642
P/2007/64, 2007-A01319-44
No
P. Flammarion, Centre Hospitalier Universitaire de Besançon
Centre Hospitalier Universitaire de Besancon
Not Provided
Principal Investigator: Nhu Uyen Nguyen, MD, PhD Centre Hospitalier Universitaire de Besançon
Centre Hospitalier Universitaire de Besancon
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP