Übersicht über
aktuelle Studien zur Prävention und Immunintervention des
Diabetes mellitus Typ 1
Survey of recent clinical trials of the prevention
and immunointervention of type 1 diabetes mellitusH. Boerschmann1,2
, M. Walter1,3
, P. Achenbach1
, A.-G Ziegler1,3
1Forschergruppe Diabetes der Technischen
Universität München
2Klinik und Poliklinik für
Kinder- und Jugendmedizin, Klinikum rechts der Isar, Technische
Universität München
3Klinikum Schwabing, Klinik für
Endokrinologie, Diabetologie, Gastroenterologie, Hepatologie und Suchtmedizin,
München
Immunmodulatorische Therapieansätze bei Diabetes mellitus
Typ 1 (T1DM) zielen auf die Verhinderung der Entstehung (Primär-)
und Progression (Sekundär-) von Inselautoimmunität bei
nicht-diabetischen Personen mit hohem Erkrankungsrisiko bzw. den
Erhalt der β-Zell-Restfunktion bei Patienten mit neu-manifestiertem Diabetes
(Tertiärprävention). Diese Arbeit soll einen Überblick über
aktuelle Immuninterventionsstudien bei T1DM geben. 1.) Die Pre-POINT-Studie
prüft eine Intervention mit oralem/nasalem Insulin,
im Sinne einer Schutzimpfung, bei Autoantikörper-negativen
Kindern mit hohem genetischem Diabetesrisiko. 2.) Die „Cord
Blood Study” untersucht die Wirksamkeit einer Transfusion
von autologem Nabelschnurblut bei Kindern mit T1DM im Hinblick auf
die β-Zell-Regeneration und Verbesserung der Blutglukose-Kontrolle.
3.) In der „GAD Vaccination Study” soll die kürzlich
in einer Phase-II-Studie nachgewiesene Wirkung einer rhGAD65-Impfung,
die zum Erhalt der β-Zell-Restfunktion bei Patienten mit T1DM
führte, in einer Phase-III-Studie mit 320 neu-erkrankten
Kindern verifiziert werden. 4.) Die AIDA-Studie prüft die
anti-inflammatorische/β-Zell-protektive Wirkung
des Interleukin-1-Rezeptor-Antagonisten Anakinra bei 80 Patienten
mit T1DM.
Abstract
Immunomodulatory strategies in the management of type 1 diabetes
mellitus (T1DM) have as their primary target the prevention of initiating islet
autoimmunity (primary-), the secondary one is the progression to
diabetes (secondary-) in non-diabetic persons at risk, and the decline of β-cell
function in new-onset patients (tertiary-prevention). This article
reviews four recent immunointervention trials in patients with T1DM.
(1) The Pre-POINT study is a primary prevention trial that will
test whether vaccination with oral or nasal insulin can prevent
the progression of islet autoimmunity and of T1DM in autoantibody-negative
children who are genetically at high diabetes risk. (2) The Cord
Blood study is a tertiary immunointervention trial that will test
whether administration of autologous umbilical cord blood to children
with T1DM can lead to regeneration of pancreatic islet insulin-producing β-cells and
improved blood glucose control. (3) The GAD Vaccination study will
test whether vaccination with alum-formulated rhGAD65 (recombinant
human glutamic acid decarboxylate) can preserve β-cell
function in 320 children with newly diagnosed T1DM, as has been
suggested in a recent phase II study. (4) The AIDA study will test
the β-cell protective effect of interleukin-1-receptor
antagonist Anakinra in 80 patients with T1DM, which has recently
been shown to improve β-cell function in patients with
type 2 diabetes.
Schlüsselwörter
Diabetes mellitus Typ 1 - Immunprävention - Immunintervention - Interventionsstudie
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