Clinical trial NCT01824680: Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake
Official title: Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Appetite regulation
Hormones
Adolescents
Exercise
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.

It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program.

Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program

Detailed description: There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session.

Each session contains : blood sample at regular interval (Leptin, Ghrélin, CCK, PYY, GLP-1), a sleeping assessment (Pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the SU.VI.MAX. tool.

During the " rest " session :

Blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. Physical condition (VO2 max, DEXA, and muscular test), insulin-sensibility, lipid profile, are also assessed.

During the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's VO2 max. The peripherical blood output is measured by a non-invasive method: the Near-Infra-Red-Spectroscopy, during the exercise.

The 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. Most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.

Eligibility criteria: Inclusion Criteria:

Overweight adolescents (over the 90 th percentile of the international cut-off point)

* With a computer and an internet connection
* Sedentary (according to the IPAQ-A questionnaire)
* Without eating disorders (according to the DEBQ questionnaire)

Exclusion Criteria:

* Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
* Drugs that could interfere with the results of the study
* Surgical intervention in the 3 months
* Regular consumption of tobacco or Alcohol
* patients on a diet with caloric restriction
* Refusal to sign the consent form
* Regular practice of sport and intensive

Primary outcomes:
measure: Comparison before and after the physical activity program of the effect of intense exercise on kinetic of secretion of regulation hormones: Leptin, Grhélin, CCK, PYY3-36, GLP-1
timeFrame: after 3 months of physical activity
Secondary outcomes:
measure: Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
timeFrame: after 3 months of physical activity
measure: Comparison, before and after the physical activity program of food intake
timeFrame: after 3 months of physical activity
measure: Comparison, before and after the physical activity program of insulinosensibility
timeFrame: after 3 months of physical activity
measure: Comparison, before and after the physical activity program of peripheral blood output
timeFrame: after 3 months of physical activity
measure: Comparison, before and after the physical activity program of sleep quality
timeFrame: agter 3 months of physical activity
measure: Comparison, before and after the physical activity program of physical condition
timeFrame: after 3 months of physical activity
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Etienne MERLIN
role: PRINCIPAL_INVESTIGATOR
References: