Diabetes Mellitus Clinical Trial
Official title:
Effect of Interleukin-1 Receptor Antagonist on Insulin Sensitivity in Type 1 Diabetes Mellitus.
The purpose of this study is to test whether anakinra is able to reduce insulin resistance.
This will be tested in overweighted type I diabetes mellitus patients, which have no
residual beta-cell function. By using this patient group, all positive effects on glycemic
control should be the consequence of improved insulin sensitivity.
Although typically associated with type 2 diabetes, insulin resistance has been documented
in Type 1 diabetes. Insulin resistance may also play an important role in the
pathophysiology of type 1 diabetes mellitus. Once diabetes has emerged chronically elevated
glucose levels further induce insulin resistance (glucose toxicity).
Inflammation is an important link between obesity and insulin resistance. The mechanism of
hyperglycemia-induced insulin resistance is not clear, but evidently must be related to high
glucose levels. There are indications that chronic hyperglycemia can induce inflammation,
for example hyperglycemia induces IL-1β release, and recent studies have shown an
interaction with thioredoxin interacting protein (TXNIP), at the level of the beta-cell but
also, as found by our own group, at the level of the adipose tissue
All together, these findings suggest that blocking IL-1β-receptor activation by the
interleukin-1 receptor antagonist anakinra, may reverse insulin resistance associated both
with obesity and/or chronic hyperglycemia. When applied in (hyperglycemic) subjects with
type 2 diabetes, blocking IL-1β should diminish the effects of glucose toxicity both at the
level of beta-cell function as at the level of insulin sensitivity. When applied in
(hyperglycemic) subjects with type 1 diabetes, the effects of glucose toxicity at the level
of insulin sensitivity should decrease.
In order to be able to study an isolated effect of IL-1β blockade on insulin sensitivity,
this study will test this hypothesis in subjects with type 1 diabetes and hence provide a
proof of principle in vivo in humans for a proposed link between hyperglycemia, inflammation
and insulin resistance.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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