- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Clermont-Ferrand, Francia, 63003
- CHU Clermont-Ferrand
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
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
Periodo de tiempo: after 3 months of physical activity
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after 3 months of physical activity
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: after 3 months of physical activity
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after 3 months of physical activity
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Etienne MERLIN, University Hospital, Clermont-Ferrand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHU-0149
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