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

March 8, 2023 updated by: Istituto Auxologico Italiano

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Verbania
      • Oggebbio, Verbania, Italy, 28824
        • Recruiting
        • Istituto Auxologico Italiano IRCCS, site Piancavallo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with Prader-Willi syndrome with BMI > 35 kg/m2

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DNA methylation
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat mass
Time Frame: 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
Time Frame: 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)
Body weight
Time Frame: 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
Time Frame: 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)
Glycometabolic profile: glucose
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 26, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01C213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prader-Willi Syndrome

Clinical Trials on Multidisciplinary metabolic rehabilitation program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe