- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00896610
Natural History of Autoimmune Diabetes and Its Complications
Background:
- Diabetes is a disease defined by abnormally high blood sugar (glucose) levels. Glucose is an essential source of energy for the body s cells, but insulin is required to move the glucose into the cells. Insulin is a hormone produced by the pancreas that allows glucose to enter cells.
- In diabetes, the body is unable to supply enough insulin to meet its demands. The problem may be a low supply of insulin or a high demand for insulin. Someone who has been diagnosed with diabetes has lost much of their insulin-producing capacity. Clinical studies have shown that good control of blood sugar is essential to prevent diabetes complications like damage to the eyes, kidneys, nerves, and blood vessels.
Objectives:
- To establish a relationship with several individuals with diabetes caused by the immune system attacking the body s insulin-producing cells in order to:
- Explore why the immune system attacks insulin-producing cells.
- Understand why some individuals develop diabetes-related complications and others do not.
- Develop therapies to improve how patients can control their blood sugar levels.
- Continue to follow subjects who have completed or are considering other NIH diabetes-related studies.
- To develop improved tests for determining an individual s risk for developing diabetes and/or to accurately diagnose the exact type of diabetes.
Eligibility:
- Individuals who have been diagnosed with or are at risk for developing diabetes.
Design:
- Standard physical examination and clinical tests to determine if the patient has diabetes or to confirm a particular type of diabetes:
- None of the treatment in this study is experimental.
- Patients will receive a separate consent form for any special tests needed to learn more about their particular type of diabetes.
- Patients may be asked to provide additional urine and blood samples for use in laboratory research about diabetes.
- Researchers may offer medical treatment advice for diabetes, or explain how to improve patients diabetes management skills.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
-INCLUSION CRITERIA:
i. Clinical diagnosis of diabetes, either type 1 (T1D) or insulin-requiring type 2 (T2D),
ii. Healthy individuals who may be at risk for developing diabetes,
iii. Individuals with suspected immune mediated diabetes,
iv. Willingness of the patient or guardian to give informed consent and assent.
EXCLUSION CRITERIA:
i. Concomitant medical problems which would confound the interpretation studies of the autoimmune beta cell destructive process
ii. Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.
iii. Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Diabetes
Individuals who have been diagnosed with or are at risk for developing diabetes
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Blood glucose level
Délai: every 3 months
|
Blood glucose level within a range appropriate for the patient's condition.
|
every 3 months
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Harlan DM, von Herrath M. Immune intervention with anti-CD3 in diabetes. Nat Med. 2005 Jul;11(7):716-8. doi: 10.1038/nm0705-716. No abstract available.
- Haines L, Wan KC, Lynn R, Barrett TG, Shield JP. Rising incidence of type 2 diabetes in children in the U.K. Diabetes Care. 2007 May;30(5):1097-101. doi: 10.2337/dc06-1813. Epub 2007 Jan 26.
- Palmer JP, Hampe CS, Chiu H, Goel A, Brooks-Worrell BM. Is latent autoimmune diabetes in adults distinct from type 1 diabetes or just type 1 diabetes at an older age? Diabetes. 2005 Dec;54 Suppl 2:S62-7. doi: 10.2337/diabetes.54.suppl_2.s62.
- Lo B, Swafford AD, Shafer-Weaver KA, Jerome LF, Rakhlin L, Mathern DR, Callahan CA, Jiang P, Davison LJ, Stevens HE, Lucas CL, White J, von Borstel R, Todd JA, Lenardo MJ. Antibodies against insulin measured by electrochemiluminescence predicts insulitis severity and disease onset in non-obese diabetic mice and can distinguish human type 1 diabetes status. J Transl Med. 2011 Nov 28;9:203. doi: 10.1186/1479-5876-9-203.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 090140
- 09-DK-0140
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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