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

NCT05778032 | Active Not Recruiting

• 1 other identifier: 01C213
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prader-Willi Syndrome

Keywords

Prader-Willi syndrome; Obesity; Biological age; Metabolic rehabilitation

Outcome Measures

Primary Outcomes (1)

• DNA methylation

  Change in level of DNA methylation

  Baseline and at the end of the rehabilitation program (21 days)

Secondary Outcomes (6)

• Glycometabolic profile: glucose

  Baseline and at the end of the rehabilitation program (21 days)

• Glycometabolic profile: insulin

  Baseline and at the end of the rehabilitation program (21 days)

• Body fat mass

  Baseline and at the end of the rehabilitation program (21 days)

• Body fat free mass

  Baseline and at the end of the rehabilitation program (21 days)

• Body weight

  Baseline and at the end of the rehabilitation program (21 days)

Interventions

Multidisciplinary metabolic rehabilitation program OTHER

Multidisciplinary metabolic rehabilitation program with a duration of 3 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• age \< 18 years
• BMI \< 35 kg/m2

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

The samples taken will be used for DNA extraction. DNA methylation will be performed by treatment with sodium bisulphite and PCR-Pyrosequencing.

MeSH Terms

Conditions

Prader-Willi Syndrome; Obesity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 21, 2023
• Study Start: May 25, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

IT (1)