- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01824680
Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake (APHRO)
Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents
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
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Clermont-Ferrand, Frankrijk, 63003
- CHU clermont-ferrand
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: obesity
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There is two sequences, one before and one after the physical activity program.
Each sequence contains one "rest" session and one "exercise" session
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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
Tijdsspanne: after 3 months of physical activity
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after 3 months of physical activity
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Tijdsspanne: after 3 months of physical activity
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after 3 months of physical activity
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Comparison, before and after the physical activity program of food intake
Tijdsspanne: after 3 months of physical activity
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after 3 months of physical activity
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Comparison, before and after the physical activity program of insulinosensibility
Tijdsspanne: after 3 months of physical activity
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after 3 months of physical activity
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Comparison, before and after the physical activity program of peripheral blood output
Tijdsspanne: after 3 months of physical activity
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after 3 months of physical activity
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Comparison, before and after the physical activity program of sleep quality
Tijdsspanne: agter 3 months of physical activity
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agter 3 months of physical activity
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Comparison, before and after the physical activity program of physical condition
Tijdsspanne: after 3 months of physical activity
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after 3 months of physical activity
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Etienne MERLIN, University Hospital, Clermont-Ferrand
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CHU-0149
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