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001-es BibID:	BIBFORM024362
Első szerző:	Schloot, Nanette C.
Cím:	Effect of heat shock protein peptide DiaPep277 on beta-cell function in paediatric and adult patients with recent-onset diabetes mellitus type 1 : two prospective, randomized, double-blind phase II trials / Nanette C. Schloot, Guido Meierhoff, Csaba Lengyel, Gyözö Vándorfi, József Takács, Pál Pánczél, László Barkai, László Madácsy, Tamás Oroszlán, Peter Kovács, Gábor Sütö, Tadej Battelino, Nora Hosszufalusi, György Jermendy
Dátum:	2007
Megjegyzések:	Background: Aim of this trial was to test whether heat shock protein peptide DiaPep277 treatment in adult and paediatric patients with recent-onset type 1 diabetes (T1D) is safe and whether it can preserve endogenous insulin production. Methods: Two studies were performed in a prospective, multicentre, double-blind, placebo-controlled trial. Fifty adult (study p520, aged 16-44 years) and 49 paediatric patients (study p521, 4-15 years) with recent-onset T1D were treated subcutaneously at four different time points with 0.2 mg or 1.0 mg DiaPep277 versus placebo and followed for 18 months. Adult patients were treated with 0.2 mg, 1.0 mg or 2.5 mg DiaPep277 versus placebo. Stimulated C-peptide served as readout for functional ?-cell-mass. Results: DiaPep277-treatment was not associated with severe side effects. No differences were found in placebo and DiaPep277 treated groups. In adults, a modest trend towards better maintenance of ?-cell function was observed in the 0.2 mg and 1.0 mg group, while there was significant loss of stimulated C-peptide in the placebo and 2.5 mg group. Paediatric patients with low HLA risk showed stable C-peptide levels until 13 months upon treatment with 1 mg DiaPep277. Despite similar stimulated C-peptide levels at baseline, children exhibited a more pronounced loss of ?-cell function over 18 months than adults (p = 0.0003). Conclusion: Administration of DiaPep277 seems safe and may have beneficial effects on C-peptide levels over time in some patients with T1D, but this finding was not accompanied by reduced HbA<sub>1c</sub> or insulin requirement. Studies with more patients and longer follow-up are needed to further study the effect of DiaPep277.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban PEPTIDES Islets of Langerhans INSULIN-SECRETING CELLS INSULIN Injections, Subcutaneous Hypoglycemic Agents Humans HLA Antigens Hemoglobin A, Glycosylated Drug Therapy, Combination Double-Blind Method Dose-Response Relationship, Drug Diabetes Mellitus, Type 1 Child C-peptide AUTOANTIBODIES Adult Adolescent urticaria unspecified side effect randomized controlled trial protein blood level priority journal phase 2 clinical trial pancreas islet cell function pancreas islet beta cell multiple drug dose multicenter study menstrual irregularity Male major clinical study insulin synthesis insulin dependent diabetes mellitus injection site dermatitis immunotherapy hypoglycemia human HLA matching high risk population hemoglobin blood level Female drug tolerance drug safety drug fever drug dose increase drug dose comparison double blind procedure dizziness controlled study controlled clinical trial clinical trial cell density ARTICLE antibody titer Age Distribution unclassified drug placebo peptide p277 mannitol HLA DR3 antigen HLA DR antigen hemoglobin A1c heat shock protein 60 diapep277 C peptide antidiabetic agent Type 1 diabetes mellitus PREVENTION Human trials Hsp60 HbA<sub>1c</sub>
Megjelenés:	Diabetes/metabolism research and reviews. - 23 : 4 (2007), p. 276-285. -
További szerzők:	Meierhoff, Guido Lengyel Csaba (Miskolc) Vándorfi Győző Takács József Pánczél Pál Barkai László (1958-) (gyermekgyógyász) Madácsy László (Szeged) Oroszlán Tamás Kovács Péter (1947-) (belgyógyász, kardiológus, klinikai farmakológus) Sütő Gábor Battelino, Tadej Hosszúfalusi Nóra Jermendy György
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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