- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02204670
EXIT: Prospective Study of the Response to Exercise (EXIT)
Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents
Background :
Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. A main factor likely to explain the exercise training variability is the lack of empirical evidence on the determinants of exercise training. A series of muscle-derived cytokines have recently been discovered that (1) are released during exercise and (2) exert positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might contributes to the metabolic adaptations to exercise training.
Methods:
The investigators will perform a pilot cohort study in which obese adolescents will perform resistance exercise training for 6 weeks. The main exposure variable will be the acute release of irisin during resistance exercise. The main outcome measures will be the change in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral glucose tolerance test.
Study Hypothesis:
The primary overall hypothesis is that the change in plasma Irisin with a single bout of exercise will be associated with the metabolic adaptations to 6 weeks of resistance training, specifically, the reductions in hepatic triglyceride content and post-prandial glucose excursions, in obese adolescents.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Winnipeg, Canadá
- The Manitoba Institute of Child Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adolescents (12-18 years)
- Body mass index considered obese according to the International Obesity Task Force
Exclusion Criteria:
- Adolescents with medication-induced or type 1 diabetes
- are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
- have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
- have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment
- a history of alcoholism or drug abuse
- require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days
- medication(s) known to cause weight gain
- anabolic steroids
- weight loss medication(s)
- pregnant or planning to be pregnant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Overweight Adolescents Performing Resistance Training
Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period.
Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training.
This will be the primary exposure variable.
After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks.
During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral).
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We will determine the amount of Irisin secreted after a single bout of resistance exercise.
Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise.
The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hepatic Triglyceride Content
Periodo de tiempo: 6 weeks
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Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy.
After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra.
A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.
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6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post-prandial glucose
Periodo de tiempo: 6 weeks
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Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jon M McGavock, PhD, University of Manitoba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- B2014:064
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