Ireland
--:--IST
Active, not recruiting Observational

Biological Age Assessment in Adults With Prader-Willi Syndrome (ETABIOLPWS)

NCT05778032 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-05-25
Last updated
2024-10-02

Condition(s) studied

Prader-Willi Syndrome

Investigational drug(s) / intervention(s)

Multidisciplinary metabolic rehabilitation program

Multidisciplinary metabolic rehabilitation program: Multidisciplinary metabolic rehabilitation program with a duration of 3 weeks

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • DNA methylation — Baseline and at the end of the rehabilitation program (21 days)
    Change in level of DNA methylation

Trial sites (1)

FacilityCityRegionStatus
Istituto Auxologico Italiano IRCCS, Site Piancavallo Oggebbio Verbania

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05778032 on ClinicalTrials.gov ↗ ← All trials in Italy