Évaluation de l'âge biologique chez les adultes atteints du syndrome de Prader-Willi (ETABIOLPWS) (ETABIOLPWS)
Évaluation de l'âge biologique chez les adultes atteints du syndrome de Prader-Willi qui suivent un programme de réadaptation métabolique multidisciplinaire intégré
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Verbania
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Oggebbio, Verbania, Italie, 28824
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adult patients with Prader-Willi syndrome with BMI > 35 kg/m2
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
DNA methylation
Délai: Baseline and at the end of the rehabilitation program (21 days)
|
Change in level of DNA methylation |
Baseline and at the end of the rehabilitation program (21 days)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Glycometabolic profile: glucose
Délai: 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)
|
|
Glycometabolic profile: insulin
Délai: 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)
|
|
Body fat mass
Délai: Baseline and at the end of the rehabilitation program (21 days)
|
Change in body fat mass - bioimpedance analysis |
Baseline and at the end of the rehabilitation program (21 days)
|
|
Body fat free mass
Délai: Baseline and at the end of the rehabilitation program (21 days)
|
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
Délai: Baseline and at the end of the rehabilitation program (21 days)
|
Change in body weight |
Baseline and at the end of the rehabilitation program (21 days)
|
|
Body mass index
Délai: Baseline and at the end of the rehabilitation program (21 days)
|
Change in body mass index |
Baseline and at the end of the rehabilitation program (21 days)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles de l'empreinte
- Manifestations neurologiques
- Maladies du système nerveux
- Troubles nutritionnels
- Maladies génétiques, innées
- Suralimentation
- Poids
- Manifestations neurocomportementales
- Anomalies congénitales
- Anomalies multiples
- En surpoids
- Déficience intellectuelle
- Troubles chromosomiques
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Obésité
- Syndrome de Prader Willi
Autres numéros d'identification d'étude
- 01C213
Informations sur les médicaments et les dispositifs, documents d'étude
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