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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Carla Di Dedda, PhD
- 電話番号:+39 0226434369
- メール:didedda.carla@hsr.it
研究連絡先のバックアップ
- 名前:Lorenzo Piemonti, MD
- 電話番号:+39 0226432706
- メール:piemonti.lorenzo@hsr.it
研究場所
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Milan、イタリア、20132
- IRCCS San Raffaele Scientific Institute
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コンタクト:
- Lorenzo Piemonti, MD
- 電話番号:+39 0226432706
- メール:piemonti.lorenzo@hsr.it
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コンタクト:
- Carla Di Dedda, PhD
- 電話番号:+39 02 26434369
- メール:didedda.carla@hsr.it
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主任研究者:
- Carla Di Dedda, PhD
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副調査官:
- Lorenzo Piemonti, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Human Immune Cell Engraftment/Reconstitution
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quantitative and Phenotypic Profile of Human Immune Cell Subsets
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Carla Di Dedda, PhD、IRCCS San Raffaele
- スタディチェア:Lorenzo Piemonti, MD、IRCCS San Raffaele
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SG-2024-12380508 (GLUT1D)
- SG-2024-12380508 (その他の識別子:Italian Ministry of Health)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。