Prader-Willi SyndromeETABIOLPWSNCT05778032
Biological Age Assessment in Adults With Prader-Willi Syndrome (ETABIOLPWS)
An observational study of Prader-Willi Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Multidisciplinary metabolic rehabilitation program
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Prader-Willi syndrome with BMI > 35 kg/m2
Who may be able to join
- 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
Who cannot join
- age < 18 years
- BMI < 35 kg/m2
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, Verbania, 28824
About this study
Official title: 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).
Read the 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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Multidisciplinary metabolic rehabilitation program
- Keywords
- Prader-Willi syndrome, Obesity, Biological age, Metabolic rehabilitation
- Medical subject headings
- Prader-Willi Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary metabolic rehabilitation programOther
Multidisciplinary metabolic rehabilitation program with a duration of 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA methylation
Change in level of DNA methylation
Measured: Baseline and at the end of the rehabilitation program (21 days)
Secondary outcomes (6)
Glycometabolic profile: glucose
Change in glycometabolic profile - glucose levels
Measured: Baseline and at the end of the rehabilitation program (21 days)
Glycometabolic profile: insulin
Change in glycometabolic profile - insulin levels
Measured: Baseline and at the end of the rehabilitation program (21 days)
Body fat mass
Change in body fat mass - bioimpedance analysis
Measured: Baseline and at the end of the rehabilitation program (21 days)
Body fat free mass
Change in body fat free mass - bioimpedance analysis
Measured: Baseline and at the end of the rehabilitation program (21 days)
Body weight
Change in body weight
Measured: Baseline and at the end of the rehabilitation program (21 days)
Body mass index
Change in body mass index
Measured: Baseline and at the end of the rehabilitation program (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start25 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778032
- Sponsor's protocol ID
- 01C213
- Acronym
- ETABIOLPWS
- Status last verified
- Oct 2024
- First submitted
- 26 Feb 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Age Assessment in Adults With Prader-Willi Syndrome Undergoing an Integrated Multidisciplinary Metabolic Rehabilitation Program
- ClinicalTrials.gov ID
- NCT05778032
- Acronym / sponsor ID
- ETABIOLPWS / 01C213
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willi syndrome, Obesity, Biological age, Metabolic rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Prader-Willi syndrome with BMI > 35 kg/m2
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- age < 18 years
- BMI < 35 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary metabolic rehabilitation programMultidisciplinary metabolic rehabilitation program with a duration of 3 weeks | Other | – |
Primary outcome
DNA methylation
Time frame: Baseline and at the end of the rehabilitation program (21 days)
Change in level of DNA methylation
6 secondary outcomes
Glycometabolic profile: glucose
Time frame: 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)
Body fat mass
Time frame: 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)
Body weight
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prader-Willi Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA methylation (time frame: Baseline and at the end of the rehabilitation program (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.