- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02675192
Biological Aging of Skeletal Muscles in Humans (BioAge)
Biological Aging of Skeletal Muscles in Humans, a Monocentric, Prospective Study
Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.
However, strong inter-individual variations of this prevalence of sarcopenia exists. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.
In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.
However, strong inter-individual variations of this prevalence of sarcopenia exists. Some elderly (60 years old) reveal a biological aging of 80 years old, whereas 60 years old people reveal a biological aging of 60 years old. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.
Previous sarcopenia studies in Humans did not really focus on chronological aging, they were all based on a comparison between young and old people. No study considered inter-individual modifications (biological aging) in sarcopenia. Furthermore, few studies were associated in the same study to "omic", histological, and epigenetic data, to obtain integrated point of view of Human Sarcopenia.
In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Saint Etienne, Francia, 42100
- Chu Saint Etienne
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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:
- Belonging to the Proof cohort
- Between 80 and 83 years old
- Informed consent signed
- Genetic analyses consent signed
- Subject affiliated or entitled to a social security scheme
Exclusion Criteria:
- Anti coagulative treatment
- Severe obesity (>35)
- All chronic pathology requiring a treatment
- Severe renal insufficiency (discovery less than 6 months)
- Abnormal coagulation appraisal
- Allergy to local anesthetics
- Installation of a prosthetic hip and / or knee in the last six months
- Senile dementia
- Refusal of genetic study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Proof cohort : muscular assessment
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Clinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The area of type IIA fibers called vastus lateralis.
Periodo de tiempo: Day 15
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The primary endpoint is the cross sectional area (measured in µm2) of type IIA fibers from the vastus lateralis muscle biopsies.
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Day 15
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: FEASSON Léonard, MD, Chu Saint Etienne
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- 1508145
- 2015-A01484-45 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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