- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07695727
Targeting GLUT1 to Control Autoimmunity in Type 1 Diabetes (GLUT1D)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type 1 Diabetes is an autoimmune disease characterized by immune-mediated destruction of pancreatic beta cells. Autoreactive T cells play a central role in this process and may persist over time within the memory T-cell compartment. Understanding the mechanisms that sustain autoreactive T-cell activation, survival, proliferation, and inflammatory function is therefore important for the development of more targeted immune-modulatory strategies.
Activated T cells undergo metabolic reprogramming to support their functional responses. In this context, glucose uptake and glycolytic metabolism are important components of T-cell activation. GLUT1 is a key glucose transporter involved in this metabolic adaptation and may contribute to the ability of autoreactive T cells to expand and maintain effector functions.
This study will use previously collected and biobanked peripheral blood mononuclear cell (PBMC) samples from individuals with Type 1 Diabetes. The PBMC samples will be retrieved in coded form, thawed, and infused into immunodeficient NOD scid gamma (NSG) mice to reconstitute a human immune system and generate humanized preclinical models. These models will be used to investigate the phenotype, activation state, metabolic profile, inflammatory function, and transcriptional features of human immune cells in relation to GLUT1 modulation. Experimental approaches include flow cytometry-based immunophenotyping, cytokine assessment, and transcriptomic analyses performed on human immune cells recovered from the humanized mice.
The study is observational and retrospective with respect to human participants. All human biological material and associated data were collected before the start of this study and are stored in coded or pseudonymized form. The study does not involve prospective enrollment of human participants, administration of an investigational product to human participants, additional biological sampling, clinical visits, or other study-specific procedures involving human participants.
The purpose of the study is to generate mechanistic and translational evidence on the role of GLUT1-dependent immune metabolism in Type 1 Diabetes-associated autoimmunity, using humanized preclinical models generated from biobanked PBMC samples. The study is intended to support the future development of targeted strategies aimed at modulating pathogenic autoreactive immune responses.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Carla Di Dedda, PhD
- Numéro de téléphone: +39 0226434369
- E-mail: didedda.carla@hsr.it
Sauvegarde des contacts de l'étude
- Nom: Lorenzo Piemonti, MD
- Numéro de téléphone: +39 0226432706
- E-mail: piemonti.lorenzo@hsr.it
Lieux d'étude
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Milan, Italie, 20132
- IRCCS San Raffaele Scientific Institute
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Contact:
- Lorenzo Piemonti, MD
- Numéro de téléphone: +39 0226432706
- E-mail: piemonti.lorenzo@hsr.it
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Contact:
- Carla Di Dedda, PhD
- Numéro de téléphone: +39 02 26434369
- E-mail: didedda.carla@hsr.it
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Chercheur principal:
- Carla Di Dedda, PhD
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Sous-enquêteur:
- Lorenzo Piemonti, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Adults With Type 1 Diabetes
Previously collected PBMC samples obtained from adult subjects with a documented diagnosis of Type 1 Diabetes and stored at the institutional Biobank of IRCCS Ospedale San Raffaele.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Human Immune Cell Engraftment/Reconstitution
Délai: 28 days after peripheral blood mononuclear cells (PBMCs) infusion
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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.
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28 days after peripheral blood mononuclear cells (PBMCs) infusion
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quantitative and Phenotypic Profile of Human Immune Cell Subsets
Délai: 28, 44, and 58 days after PBMC infusion
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Human immune cell subsets will be quantitatively and phenotypically analyzed after in vivo reconstitution in recipient NSG mice.
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28, 44, and 58 days after PBMC infusion
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Carla Di Dedda, PhD, IRCCS San Raffaele
- Chaise d'étude: Lorenzo Piemonti, MD, IRCCS San Raffaele
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SG-2024-12380508 (GLUT1D)
- SG-2024-12380508 (Autre identifiant: Italian Ministry of Health)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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