- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06322212
Diabète de type 2 et amélioration de la barrière hémato-encéphalique
Diabète sucré de type 2 et amélioration de la barrière hémato-encéphalique - Un essai clinique randomisé
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Le diabète sucré de type 2 (DT2) représente 90 à 95 % de tous les diabètes sucrés diagnostiqués et constitue un problème de santé grave aux États-Unis.1 Les adultes atteints de DT2 présentent des déficits émotionnels et cognitifs importants, des symptômes associés à une morbidité et une mortalité plus élevées, de mauvais soins personnels et une qualité de vie réduite, et cette maladie est liée à la démence précoce et à la maladie d'Alzheimer. Des changements structurels cérébraux apparaissent chez les adultes DT2 dans des sites qui exercent une influence majeure sur les fonctions cognitives et de l'humeur, résultant potentiellement d'une altération de la fonction de la barrière hémato-encéphalique (BBB). Cependant, il n'est pas clair si la fonction BBB peut être réparée chez les adultes atteints de DT2, réduisant ainsi les troubles de la cognition et de l'humeur ainsi que les risques précoces de démence et de maladie d'Alzheimer dans cette maladie.
Plusieurs études précliniques suggèrent la possibilité d'une réparation de la fonction BBB, y compris une intervention à faible coût à base de thiamine. La thiamine est un cofacteur essentiel pour le métabolisme des glucides et des niveaux adéquats ou supérieurs favorisent le métabolisme aérobie et réduisent les lésions neuronales. De plus, il a été démontré que des niveaux réduits de thiamine contribuent à une altération des fonctions des cellules endothéliales et que des doses plus élevées de traitement à la thiamine améliorent les fonctions endothéliales. Ainsi, des niveaux plus faibles de thiamine peuvent contribuer à des dysfonctionnements des cellules neuronales et endothéliales, entraînant une altération de la fonction BBB. La majorité des adultes DT2 présentent une carence en thiamine, ce qui peut contribuer à une altération de la fonction BBB, mais il n'est pas clair si le traitement à la thiamine peut améliorer la fonction BBB chez les adultes DT2. Les enquêteurs émettent l'hypothèse qu'une intervention à la thiamine (3 mois) réduira l'altération de la fonction BBB et améliorera les fonctions cognitives et de l'humeur chez les adultes DT2 traités à la thiamine par rapport aux adultes DT2 non traités.
En résumé, les enquêteurs proposent qu'un traitement à la thiamine à faible coût pendant 3 mois chez les adultes DT2 réparera le dysfonctionnement de la BHE et améliorera l'humeur et les fonctions cognitives. Si les études aboutissent, les résultats de cet essai clinique pourraient servir de stratégie thérapeutique nouvelle et innovante pour réparer la fonction BBB, affectant moins la cognition et la fonction de l'humeur, et donc de meilleurs résultats chez les adultes atteints de DT2, ainsi que dans d'autres conditions adultes avec une fonction BBB altérée. . Cette étude d'essai clinique exploratoire R21 fournira les données requises concernant les avantages d'une intervention à faible coût à base de thiamine qui pourrait être mise en œuvre dans le cadre d'un essai clinique à grande échelle pour réparer la fonction BBB chez les adultes DT2, conformément à la mission des National Institutes of Health, et ainsi, diminuer les risques précoces de démence et de maladie d'Alzheimer, réduire la morbidité et la mortalité et augmenter la qualité de vie de cette population de patients atteints de DT2 grave et courante.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rajesh Kumar, PhD
- Numéro de téléphone: 310-206-1699
- E-mail: rkumar@mednet.ucla.edu
Sauvegarde des contacts de l'étude
- Nom: Bhaswati Roy, PhD
- Numéro de téléphone: 310-206-6133
- E-mail: broy@mednet.ucla.edu
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095
- UCLA
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Critère d'intégration:
- DT2 diagnostiqué
- Statut ambulatoire
- Capable de poser à plat pour l'imagerie
Critère d'exclusion:
- Des antécédents d’accident vasculaire cérébral
- Apport actuel de thiamine
- Allergie connue à la thiamine
- Trouble épileptique
- Un traumatisme crânien
- Infarctus du myocarde
- Grossesse actuelle (si femme)
- Troubles neuropsychiatriques diagnostiqués (dépression clinique, schizophrénie, maniaco-dépression)
- Démence diagnostiquée
- Troubles respiratoires du sommeil
- Déformations des voies respiratoires ou de la poitrine qui pourraient gêner la respiration
- Bronchopneumopathie chronique obstructive
- Fibrose kystique
- Présence de lésions de masse cérébrale
- Tout antécédent d'abus de drogues (par exemple, cocaïne, tabac ou cannabis)
- Insuffisance rénale (nécessitant une dialyse)
- Tous les adultes DT2 porteurs d'implants métalliques et électroniques (stimulateurs phréniques ou cardiaques ; bien que certains stimulateurs cardiaques et défibrillateurs automatiques soient sûrs à un faible champ magnétique, ils ne le sont pas avec un scanner de 3,0 Tesla)
- Pompe à insuline/capteur de glucose non amovible
- Croisillons
- Poids corporel supérieur à 300 livres (le poids et la taille seront utilisés pour calculer l'IMC afin de déterminer si le patient rentrera dans le scanner et restera dans les paramètres de restrictions de taille de la table du scanner IRM)
- Toute autre contre-indication à l'IRM, telle que la claustrophobie ou les tatouages à base de métal, selon les suggestions du site Web sur la sécurité de l'IRM, sera également exclue.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Fonction BBB, cognition et humeur chez les adultes DT2 traités à la thiamine.
Analysez la fonction BBB, la cognition et l'humeur chez les adultes DT2 traités à la thiamine et comparez-les au groupe placebo.
|
Les participants recevront des instructions pour prendre une capsule de 500 mg de thiamine (vitamine B1) chaque jour le matin pendant 3 mois.
Autres noms:
|
Comparateur placebo: Fonction BBB, cognition et humeur chez les adultes DT2 sans traitement à la thiamine.
Analysez la fonction BBB, la cognition et l'humeur chez les adultes DT2 sans traitement à la thiamine et comparez-les au groupe de traitement à la thiamine.
|
Les participants recevront des instructions pour prendre une capsule (placebo) chaque jour le matin pendant 3 mois.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Évaluez si la fonction BBB a été réparée.
Délai: Après 3 mois
|
Évaluez la fonction de la barrière hémato-encéphalique.
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Après 3 mois
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Analyser les niveaux sériques de S100β dans le sérum sanguin.
Délai: Après 3 mois
|
Analysez les taux sériques de S100β (marqueur de l'intégrité de la BBB) pour voir s'ils ont été réduits chez les adultes DT2 traités à la thiamine par rapport aux adultes DT2 sans traitement à la thiamine.
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Après 3 mois
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Examiner la cognition chez les adultes DT2 traités à la thiamine.
Délai: Après 3 mois
|
L'enquêteur examinera la cognition à l'aide du Wide Range Assessment of Memory and Learning 2 (WRAML2) pour voir si les adultes DT2 traités à la thiamine présentent une cognition améliorée par rapport aux adultes DT2 sans traitement à la thiamine.
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Après 3 mois
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Évaluation cognitive chez les adultes DT2 après un traitement à la thiamine.
Délai: Après 3 mois
|
L'enquêteur évaluera la cognition à l'aide du Montreal Cognitive Assessment (MoCA) pour voir si les adultes DT2 traités à la thiamine présentent une cognition améliorée par rapport aux adultes DT2 sans traitement à la thiamine.
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Après 3 mois
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Examiner la dépression chez les adultes DT2 traités à la thiamine.
Délai: Après 3 mois
|
L'enquêteur examinera la dépression à l'aide du Beck Depression Inventory II (BDI-II) pour voir si les adultes DT2 traités à la thiamine ont une amélioration de l'humeur par rapport aux adultes DT2 sans traitement à la thiamine.
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Après 3 mois
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Évaluer l'anxiété chez les adultes DT2 recevant un traitement à la thiamine.
Délai: Après 3 mois
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L'enquêteur évaluera l'anxiété à l'aide du Beck Anxiety Inventory (BAI) pour voir si les adultes DT2 avec traitement à la thiamine ont une amélioration de l'humeur par rapport aux adultes DT2 sans traitement à la thiamine.
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Après 3 mois
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
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- Centers for Disease Control and Prevention.National Diabetes Statistics Report: Estimates of diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014.
Dates d'enregistrement des études
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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
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Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
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Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 23-001083
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Description du régime IPD
Délai de partage IPD
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Type d'informations de prise en charge du partage d'IPD
- RSE
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