Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2020-08-08
2023-12-31
Brief Summary
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The aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as TMEM219.
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Detailed Description
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Duration of the study: 5 years.
EXPERIMENTAL PROCEDURE:
The following analyses will be performed on the collected and received samples:
* Study of TMEM219 expression and of other TMEM219-related markers by immunohistochemistry and immunofluorescence and western blot
* Study of TMEM219 expression and of other TMEM219-related markers by molecular biology analysis
* Analysis of the proteomic profile on collected biological liquids The above analyses will be performed at the Pediatric Clinical Research Center Romeo ed Enrica Invernizzi at the Sacco Hospital - University of Milan.
PREVIOUS EXPERIENCES The investigatore expertise in manipulating / studying the signaling involved in the pathogenesis of type 1 diabetes has been widely recognized in several publications in recent years (Diabetes 2013, Diabetes 2014, Diabetes 2015, Science Translational Medicine 2017) as well as the characterization of marker expression including TMEM219 (Cell Stem Cell 2015).
RELEVANCE OF THE STUDY The study offers the possibility to acquire new information on the pathogenesis of diabetes and to identify new target mechanisms for designing innovative therapeutic strategies in the treatment of diabetes.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Healthy subjects
Healthy subjects without diabetes, no recent surgery interventions, no malignancies no pregnancy.
No intervention. No age limit.
No interventions assigned to this group
T1D individuals
Type 1 diabetic individuals with at least 3-year of duration of the disease. No recent surgery interventions, no malignancies no pregnancy.
No intervention. No age limit.
No interventions assigned to this group
T2D individuals
Type 2 diabetic individuals with at least 5-year duration of the disease. No recent surgery interventions, no malignancies no pregnancy.
No intervention. No age limit.
No interventions assigned to this group
AutoAb+ individuals
Individuals at risk for type 1 diabetes, with one or more autoantibody detected. No recent surgery interventions, no malignancies no pregnancy.
No intervention. No age limit.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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University of Milan
OTHER
Responsible Party
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Paolo Fiorina, MD
Professor of Endocrinogy University of Milan, Director of Endocrinology and Diabetology Unit ASST Fatebenefratelli-Sacco
Principal Investigators
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Paolo Fiorina, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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Pediatric Clinical Research Center
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Paolo Fiorina
Role: primary
Other Identifiers
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2018/ST/080
Identifier Type: -
Identifier Source: org_study_id
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