Targeting GLUT1 to Control Autoimmunity in Type 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
Type 1 Diabetes is an autoimmune disease in which immune cells contribute to the destruction of insulin-producing pancreatic beta cells. This study investigates whether targeting glucose transporter 1 (GLUT1), a transporter involved in immune cell metabolism, may help modulate autoimmune responses associated with Type 1 Diabetes.
The study uses previously collected and biobanked peripheral blood mononuclear cells (PBMCs) from individuals with Type 1 Diabetes. No additional visits, blood draws, or study-specific procedures will be performed on human participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
PBMC samples obtained from adult subjects aged 18 years or older at the time of sample collection.
Documented diagnosis of Type 1 Diabetes.
PBMC samples already collected and stored in the institutional Biobank of IRCCS Ospedale San Raffaele.
PBMC samples obtained from subjects who had previously provided written informed consent for the collection, storage, and research use of biological material and associated data.
Disqualifiers
PBMC samples obtained from subjects younger than 18 years at the time of sample collection.
Presence of relevant concomitant diseases or clinical conditions that, in the Investigator's judgment and based on available records, may interfere with the interpretation of immunological analyses or with the study objectives.
Insufficient sample availability, inadequate sample quality, or missing essential sample-related information preventing use of the PBMC sample for the planned research activities.
Trial population
Adult individuals with a documented diagnosis of Type 1 Diabetes whose peripheral blood mononuclear cell (PBMC) samples were previously collected and stored at the institutional Biobank/Biological Resources Center of IRCCS Ospedale San Raffaele. The study population consists of subjects who previously provided informed consent for the collection, storage, and research use of biological material and associated coded data. No prospective enrollment, additional sampling, or other study-specific procedures involving human participants are planned.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
84 Participants
are grouped into 1 trial groupGroup A: Adults With Type 1 Diabetes
Trial outcomes
Primary outcomes
1
Human Immune Cell Engraftment/Reconstitution
Successful human immune cell engraftment/reconstitution will be assessed by detection and quantification of human CD45-positive cells and relevant immune cell subsets in peripheral blood and lymphoid tissues of recipient NOD scid gamma (NSG) mice.
Time frame
28 days after peripheral blood mononuclear cells (PBMCs) infusionSecondary outcomes
1
Quantitative and Phenotypic Profile of Human Immune Cell Subsets
Human immune cell subsets will be quantitatively and phenotypically analyzed after in vivo reconstitution in recipient NSG mice.
Time frame
28, 44, and 58 days after PBMC infusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: