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

Prader-Willi Syndrome Clinical Trial

— ETABIOLPWS  

Official title:

Biological Age Assessment in Adults With Prader-Willi Syndrome Undergoing an Integrated Multidisciplinary Metabolic Rehabilitation Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778032
• Other study ID #: 01C213
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Alessandro Sartorio, MD
• Phone: +390261911
• Email: sartorio[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS, Site Piancavallo	Oggebbio	Verbania

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation	Change in level of DNA methylation	Baseline and at the end of the rehabilitation program (21 days)
Secondary	Glycometabolic profile: glucose	Change in glycometabolic profile - glucose levels	Baseline and at the end of the rehabilitation program (21 days)
Secondary	Glycometabolic profile: insulin	Change in glycometabolic profile - insulin levels	Baseline and at the end of the rehabilitation program (21 days)
Secondary	Body fat mass	Change in body fat mass - bioimpedance analysis	Baseline and at the end of the rehabilitation program (21 days)
Secondary	Body fat free mass	Change in body fat free mass - bioimpedance analysis	Baseline and at the end of the rehabilitation program (21 days)
Secondary	Body weight	Change in body weight	Baseline and at the end of the rehabilitation program (21 days)
Secondary	Body mass index	Change in body mass index	Baseline and at the end of the rehabilitation program (21 days)