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Detection of C-peptide in Youth With Longstanding Type 1 Diabetes Mellitus
2 mai 2014 mis à jour par: Icahn School of Medicine at Mount Sinai
Observational Study of C-peptide Levels in Youth With Longstanding Type 1 Diabetes Mellitus as Detected by an Ultrasensitive Assay
Background Type 1 diabetes is characterized by pancreatic beta-cell destruction and an inability to synthesize insulin.
Connecting peptide (C-peptide) is formed from the same precursor as insulin and is produced in equimolar amounts as insulin.
There are several clinical trials currently being performed to explore the possibility of beta-cell preservation or regeneration.
Most children are not eligible for these trials because it is often presumed that C-peptide levels will decrease and become undetectable after years of having type 1 diabetes.
Several studies in the adult population have demonstrated that C-peptide may remain measureable in patients who have had diabetes for up to 50 years after diagnosis.
Recently, it was demonstrated that 10% of adult patients who have had type 1 diabetes for 31-40 years have measureable levels of serum C-peptide if measured with an ultrasensitive assay.
The levels were lower in patients who had diabetes for a longer time.
This pattern was also demonstrated in the Diabetes Control and Complications Trial (DCCT) and NHANES trial.
No studies have been performed exclusively in pediatric patients Hypothesis The investigators hypothesize that C-peptide should be detectable in the sera of pediatric patients who have had type 1 diabetes for greater than 1 year and as far out as > 20 years after diagnosis.
The investigators also hypothesize that since their patient population has had diabetes for less time as compared to adults, the levels of C-peptide should be higher than reported for adults and that a greater proportion of patients in the pediatric population will have detectable C-peptide levels as compared to adults.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
1) Objectives:
- To determine if C-peptide is detectable in the sera of children that have had type 1 diabetes for more than 1 year using an ultrasensitive assay.
- To correlate C-peptide levels with duration since diagnosis, current age, antibody titers at diagnosis, hemoglobin A1c, total daily insulin dosage.
- To determine responsiveness of residual C-peptide to mixed-meal testing.
Type d'étude
Observationnel
Inscription (Réel)
50
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
New York
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New York, New York, États-Unis, 11103
- Icahn School of Medicine at Mount Sinai
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
1 an à 21 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Subjects will be recruited from the population of patients seen in the Division of Pediatric Endocrinology and Diabetes.
These patients must have type 1 diabetes and must have been diagnosed more than 1 year prior to their recruitment.
Potential subjects will be identified by reaching out to the physicians in the division and asking that they inform the investigators of patients that they see with type 1 diabetes.
Those patients will have their information reviewed by the investigators using EPIC, the electronic medical record at The Mount Sinai Hospital.
La description
Inclusion Criteria:
- Male or female
- 1-25 years of age
- Have had type 1 diabetes for more than 1 year.
Exclusion Criteria:
- Does not meet inclusion criteria
- Foster children
- Patients without primary caregiver
- Pregnant
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Boost shake
children that have had type 1 diabetes for more than 1 year
|
Blood draw after mixed-meal consumption
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
C-peptide level
Délai: Day 1
|
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hemoglobin A1c
Délai: Day 1
|
Hemoglobin A1c at diabetes diagnosis and at most recent medical visit will be correlated with C-peptide level
|
Day 1
|
|
Total daily dose of insulin
Délai: Day 1
|
Total daily dose of insulin per kilogram will be correlated with C-peptide level
|
Day 1
|
|
Age at diabetes diagnosis
Délai: Day 1
|
Age at diabetes diagnosis will be correlated with C-peptide level
|
Day 1
|
|
Duration of diabetes
Délai: Day 1
|
Duration of diabetes will be correlated with C-peptide level
|
Day 1
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Robert Rapaport, MD, Icahn School of Medicine at Mount Sinai
- Chercheur principal: Evan Graber, DO, Icahn School of Medicine at Mount Sinai
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.
- Sperling MA, Weinzimer SA, Tamborlane WV. Diabetes Mellitus. In: Sperling MA ed. Pediatric Endocrinology. 3rd ed. Philadelphia, PA: Saunders Elsevier; 2008:385
- Orban T, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Marks JB, Monzavi R, Moran A, Raskin P, Rodriguez H, Russell WE, Schatz D, Wherrett D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Abatacept Study Group. Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jul 30;378(9789):412-9. doi: 10.1016/S0140-6736(11)60886-6. Epub 2011 Jun 28.
- Pescovitz MD, Greenbaum CJ, Krause-Steinrauf H, Becker DJ, Gitelman SE, Goland R, Gottlieb PA, Marks JB, McGee PF, Moran AM, Raskin P, Rodriguez H, Schatz DA, Wherrett D, Wilson DM, Lachin JM, Skyler JS; Type 1 Diabetes TrialNet Anti-CD20 Study Group. Rituximab, B-lymphocyte depletion, and preservation of beta-cell function. N Engl J Med. 2009 Nov 26;361(22):2143-52. doi: 10.1056/NEJMoa0904452.
- Gottlieb PA, Quinlan S, Krause-Steinrauf H, Greenbaum CJ, Wilson DM, Rodriguez H, Schatz DA, Moran AM, Lachin JM, Skyler JS; Type 1 Diabetes TrialNet MMF/DZB Study Group. Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new- onset type 1 diabetes. Diabetes Care. 2010 Apr;33(4):826-32. doi: 10.2337/dc09-1349. Epub 2010 Jan 12.
- Wang L, Lovejoy NF, Faustman DL. Persistence of prolonged C-peptide production in type 1 diabetes as measured with an ultrasensitive C-peptide assay. Diabetes Care. 2012 Mar;35(3):465-70. doi: 10.2337/dc11-1236.
- Keenan HA, Sun JK, Levine J, Doria A, Aiello LP, Eisenbarth G, Bonner-Weir S, King GL. Residual insulin production and pancreatic ss-cell turnover after 50 years of diabetes: Joslin Medalist Study. Diabetes. 2010 Nov;59(11):2846-53. doi: 10.2337/db10-0676. Epub 2010 Aug 10.
- Effects of age, duration and treatment of insulin-dependent diabetes mellitus on residual beta-cell function: observations during eligibility testing for the Diabetes Control and Complications Trial (DCCT). The DCCT Research Group. J Clin Endocrinol Metab. 1987 Jul;65(1):30-6. doi: 10.1210/jcem-65-1-30.
- Greenbaum CJ, Anderson AM, Dolan LM, Mayer-Davis EJ, Dabelea D, Imperatore G, Marcovina S, Pihoker C; SEARCH Study Group. Preservation of beta-cell function in autoantibody-positive youth with diabetes. Diabetes Care. 2009 Oct;32(10):1839-44. doi: 10.2337/dc08-2326. Epub 2009 Jul 8.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2012
Achèvement primaire (Réel)
1 décembre 2013
Achèvement de l'étude (Réel)
1 décembre 2013
Dates d'inscription aux études
Première soumission
8 avril 2014
Première soumission répondant aux critères de contrôle qualité
2 mai 2014
Première publication (Estimation)
6 mai 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
6 mai 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 mai 2014
Dernière vérification
1 mai 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GCO 12-1425
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