- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00951392
Implication of Metabolic and Genomic Modifications in Elderly Subjects (COMPALICLAMP)
An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle).
In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging.
The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pierre-Bénite, Francia, 69495
- Centre de Recherche en Nutrition Humaine Rhône-Alpes
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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:
- Volunteers from the cohort aging SUVIMAX 2
- Men and Women
- over 60 years
- BMI between 18 and 35 kg/m2 (including terminals)
- Normal medical check up
- Blood pressure < 140/90 mmHg
- Normal glycemia, lipid profile
- sedentary or moderate physical activity (maximum 4 hours per week)
Exclusion Criteria:
- Biological results or anormal chek-up
- medical or surgical history not compatible with study
- severe digestive, cardiovascular, renal, liver or tumor disorders history in the 5 last years
- infectious or inflammatory disease within 2 months
- surgical history within 3 months
- bood donation within 2 months
- coagulation disease, anticoagulant or antiplatelet agents (aspirin ...) treatment
- xylocaïn allergy
- claustrophobia
- Drug that could affect insulin sensitivity (beta blockers, lipid lowering, oral antidiabetics, insulin, , steroids)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Problematic aging
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Insulin perfusion at 1 mU.kg-1.min-1 Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l Blood tests Gene expression in muscle tissue will be studied with two approaches :
energy expenditure measurement
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Experimental: successful aging
|
Insulin perfusion at 1 mU.kg-1.min-1 Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l Blood tests Gene expression in muscle tissue will be studied with two approaches :
energy expenditure measurement
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality
Periodo de tiempo: 120 minutes
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120 minutes
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Gene expression in muscle tissue by quantitative RT-PCR: genes involved in the carbohydrates and lipids metabolism (lipid carriers, PPARs), 7 sirtuins isoforms and of their target genes (NFkB, PGC1a)
Periodo de tiempo: one day
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one day
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Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip
Periodo de tiempo: one day
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one day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Martine LAVILLE, MD, PhD, Centre de Recherche en Nutrition Humaine Rhône-Alpes
Publicaciones y enlaces útiles
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 (Actual)
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
- 2008.547
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