Characterization of Serum Proteome in Subjects With Prader Willi Syndrome (PROTEOMARKER)
PROTEOMARKER
1 other identifier
observational
52
1 country
1
Brief Summary
The lack of serum markers that can be used to identify the levels of steatosis in obese subjects, or that can indicate a rapid progression of the metabolic disease, in which it is very often difficult to perform analyzes with imaging techniques, limits the current evolution from a generalized medicine to a personalized medicine. With the project proposal the aim is to identify serum markers for the characterization of steatosis in subjects affected by genetic obesity, which will most likely also be used in metabolic obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2022
CompletedFirst Submitted
Initial submission to the registry
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedFebruary 12, 2024
March 1, 2023
6 months
February 27, 2023
February 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Characterization of serum proteome
Evaluation of 1500 protein targets that are involved in the development of metabolic diseases
Baseline
Secondary Outcomes (2)
Relationships with basal resting energy expenditure
Baseline
Relationships with body composition parameters (evaluated throughout bioimpedentiometry)
Baseline
Study Arms (2)
Steatosis grade 2-3
Subjects with Prader-Willi syndrome and with steatosis grade 2-3
Steatosis grade 0-1
Subjects with Prader-Willi syndrome and with steatosis grade 0-1
Interventions
Serum collection for proteomic analysis
Eligibility Criteria
Adult patients with Prader-Willi syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, Verbania, 28824, Italy
Biospecimen
Plasma and serum sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2023
First Posted
March 9, 2023
Study Start
April 28, 2022
Primary Completion
October 28, 2022
Study Completion
October 28, 2022
Last Updated
February 12, 2024
Record last verified: 2023-03