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Targeting GLUT1 to Control Autoimmunity in Type 1 Diabetes (GLUT1D)

10 juli 2026 uppdaterad av: Carla Di Dedda, IRCCS San Raffaele

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.

Studieöversikt

Status

Har inte rekryterat ännu

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

84

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

      • Milan, Italien, 20132
        • IRCCS San Raffaele Scientific Institute
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Carla Di Dedda, PhD
        • Underutredare:
          • Lorenzo Piemonti, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Human Immune Cell Engraftment/Reconstitution
Tidsram: 28 days after peripheral blood mononuclear cells (PBMCs) infusion
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.
28 days after peripheral blood mononuclear cells (PBMCs) infusion

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quantitative and Phenotypic Profile of Human Immune Cell Subsets
Tidsram: 28, 44, and 58 days after PBMC infusion
Human immune cell subsets will be quantitatively and phenotypically analyzed after in vivo reconstitution in recipient NSG mice.
28, 44, and 58 days after PBMC infusion

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Carla Di Dedda, PhD, IRCCS San Raffaele
  • Studiestol: Lorenzo Piemonti, MD, IRCCS San Raffaele

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2029

Avslutad studie (Beräknad)

1 september 2029

Studieregistreringsdatum

Först inskickad

6 juli 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

10 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared. The study uses previously collected and biobanked PBMC samples together with associated pseudonymized data. Data sharing will be limited to aggregate or de-identified results, in accordance with applicable privacy regulations, ethics committee approval, institutional policies, and the informed consent provided by participants.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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