Diabetes, Type I Clinical Trial
Official title:
Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17
years duration and a second research kidney biopsy, could enter the double blind treatment
study of Atacand or Placebo.
The treatment study continues for five years treatment and ends with a third kidney biopsy.
The study hypothesis is that the effect of ARB during 5 years on the histopathology are more
pronounced than the effect on histopathology of placebo.
46 patients performed a first kidney biopsy between 1992-1994. After 6 years 29 accepted to
perform a second biopsy. During the follow-up 10 patients developed complications i.e.
hypertension or microalbuminuria. 7 of the patients got treatment during follow up and 3
started the treatment after the second biopsy. 19 patients with two kidney biopsies were
still normoalbuminuric and normotensive. 13 of them entered the double-blind treatment study
of Atacand or Placebo. 6 denied to participate in the treatment study.
The treatment study will continue for 5 years and will end with a third kidney biopsy. Also
the rest of the patients that have done 2 kidney biopsies will be asked to perform a third
biopsy.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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