Clinical trial NCT01188642: Effects of Physical Training and Nutrition Education on Adipocytokines in Severely Obese Teenagers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Obesity
Keywords: childhood obesity
adipocytokines
physical exercise
nutrition education
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese teenagers

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adipocytokines (leptin, adiponectin, ghrelin, PAI-1, resistin), based on subject's arterialized capillary blood samples.
timeFrame: during a lifestyle intervention of 9 months
Secondary outcomes:
measure: Body weight, body mass index, waist and hip circumference
timeFrame: during a lifestyle intervention of 9 months
measure: Body composition, calculated by a multifrequency bioelectric impedance
timeFrame: during a lifestyle intervention of 9 months
measure: Glycemia and lipids profile, based on subject's arterialized capillary blood samples analysis.
timeFrame: during a lifestyle intervention of 9 months
measure: Insulin resistance, calculated according to the formula of homeostasis model assessment
timeFrame: during a lifestyle intervention of 9 months
measure: Systolic and diastolic blood pressure, measured in millimeters of mercury at the level of the left brachial artery, using an automatic blood pressure monitor.
timeFrame: during a lifestyle intervention of 9 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Nhu Uyen Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.