Evaluación de la edad biológica en adultos con síndrome de Prader-Willi (ETABIOLPWS) (ETABIOLPWS)
Evaluación de la edad biológica en adultos con síndrome de Prader-Willi sometidos a un programa integrado multidisciplinario de rehabilitación metabólica
The primary objective of the study is to compare, in a cohort of obese subjects with PWS hospitalized at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo (VB), Italy, the age acceleration calculated at study entry (T0) with the age acceleration measured at the end of a 3-week multidisciplinary metabolic rehabilitation program (T1).
Secondary objectives are to correlate the biological age with the anthropometric characteristics (with particular reference to the body composition), the glycometabolic picture, the main parameters and cardiovascular risk factors, the therapy (previous and concomitant) with rhGH and the cognitive function (mainly, the IQ).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Methods Thirty adults affected by clinically diagnosed and genetically confirmed PWS are recruited, regardless of the treatment (previous or concomitant) with rhGH (F/M = 15/15; age: ≥ 18 years; BMI > 35 kg/m2), hospitalized for a period of integrated multidisciplinary metabolic rehabilitation at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo (VB), Italy.
After verifying the inclusion criteria, clinical and anthropometric data will be collected, including the evaluation of body composition with bioimpedance analysis. Cognitive function will be assessed with a psychometric scale (Wechsler Adult Intelligence Scale).
Blood samples will be taken from each patient upon admission to the hospital (T0) and after 3 weeks of rehabilitation hospitalization (at the same time to reduce circadian variability) for the determination of the basal glycometabolic profile (glucose, insulin, HOMA-IR, glycated Hb , triglycerides, total cholesterol, LDL, HDL, and hsPCR), as well as circulating levels of leptin, IL-6, and TNF-α.
The samples taken will be used for DNA extraction. DNA methylation will be performed by treatment with sodium bisulphite and PCR-Pyrosequencing.
Biological age measurement Biological (epigenetic) age will be measured using the two algorithms of Zbiec-Piekarska (9) and Daunay (10), based on the level of DNA methylation in specific gene loci. To have an estimate of the epigenetic (biological) age that is independent of the chronological age, we will use a measure defined as age acceleration, from which, with statistical inference, we will calculate the age acceleration. To calculate it, a linear regression model with the chronological age as the independent variable and the epigenetic age as the dependent variable will be applied; the difference between the observed value and the one predicted by the model will constitute the age acceleration due to epigenetic effects. In the event that the epigenetic age is greater than the chronological age, the age acceleration will have a positive value expressed in years, negative if vice versa.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Verbania
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Oggebbio, Verbania, Italia, 28824
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
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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
Adult patients with Prader-Willi syndrome with BMI > 35 kg/m2
Descripción
Inclusion Criteria:
- adult patients with PWS, clinically diagnosed and genetically confirmed, regardless of rhGH treatment (previous or concomitant)
- age: ≥ 18 years
- BMI > 35 kg/m2
- hospitalization for integrated multidisciplinary metabolic rehabilitation program
Exclusion Criteria:
- age < 18 years
- BMI < 35 kg/m2
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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DNA methylation
Periodo de tiempo: Baseline and at the end of the rehabilitation program (21 days)
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Change in level of DNA methylation |
Baseline and at the end of the rehabilitation program (21 days)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Glycometabolic profile: glucose
Periodo de tiempo: Baseline and at the end of the rehabilitation program (21 days)
|
Change in glycometabolic profile - glucose levels |
Baseline and at the end of the rehabilitation program (21 days)
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Glycometabolic profile: insulin
Periodo de tiempo: Baseline and at the end of the rehabilitation program (21 days)
|
Change in glycometabolic profile - insulin levels |
Baseline and at the end of the rehabilitation program (21 days)
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Body fat mass
Periodo de tiempo: Baseline and at the end of the rehabilitation program (21 days)
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Change in body fat mass - bioimpedance analysis |
Baseline and at the end of the rehabilitation program (21 days)
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Body fat free mass
Periodo de tiempo: Baseline and at the end of the rehabilitation program (21 days)
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Change in body fat free mass - bioimpedance analysis |
Baseline and at the end of the rehabilitation program (21 days)
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Body weight
Periodo de tiempo: Baseline and at the end of the rehabilitation program (21 days)
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Change in body weight |
Baseline and at the end of the rehabilitation program (21 days)
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Body mass index
Periodo de tiempo: Baseline and at the end of the rehabilitation program (21 days)
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Change in body mass index |
Baseline and at the end of the rehabilitation program (21 days)
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Colaboradores e Investigadores
Patrocinador
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 (Actual)
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
- Trastornos de impronta
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Trastornos Nutricionales
- Enfermedades Genéticas Congénitas
- Sobrenutrición
- Peso corporal
- Manifestaciones neuroconductuales
- Anomalías congénitas
- Anomalías Múltiples
- Exceso de peso
- Discapacidad intelectual
- Trastornos cromosómicos
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Síndrome de Prader-Willi
Otros números de identificación del estudio
- 01C213
Información sobre medicamentos y dispositivos, documentos del estudio
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