The therapeutic goal normoglycemia can not realized in most children a
nd adolescents suffering from typs 1 diabetes. Many of them develop mi
crovascular complications later in life. There were many trials to pre
vent the destruction of functioning beta-cells after onset of diabetes
. All of them could not restore the insulin secretion. II is necessary
to intervene at an earlier stage in the disease process and to stop t
he autoimmune destruction of beta-cells. Nicotinamide, a derivative of
the B-3 vitamin nicotinic acid, has been shown to prevent both chemic
ally-induced and spontaneous development in animal models of typ 1 dia
betes. These observations have led to clinical pilot trials in first d
egree relatives at increased risk of progressing to clinical disease.
To clarify the effect of oral nicotinamide in the prevention of type 1
diabetes DENIS (Deutsche Nicotinamid Interventionsstudie) - a prospec
tive, randomized, placebo controlled study - was planned. This study s
tarted 1993. First degree relatives (age 3-12 years) at increased risk
to clinical disease (ICA greater than or equal to 20 IDF units) were
offered treatment. At this time 37 children are treated. To evaluate t
he preventive effect of nicotinamid 70-80 probands are needed. The ind
ividual treatment lasts 5 years.