Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
This trial is active, not recruiting.
|Condition||diabetes, type i|
|Sponsor||Karolinska University Hospital|
|Start date||September 2000|
|End date||April 2006|
|Trial size||13 participants|
|Trial identifier||NCT00328302, SH-AHM-0044-01|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Basement membrane thickness
24 hour ambulatory blood pressure
Male or female participants from 17 years up to 30 years old.
Inclusion Criteria: - Diabetes type 1 patient - Normotensive - Normoalbuminuric - Signed informed consent - Female and male - Over 17 years of age - Diabetes duration over 10 years Exclusion Criteria: - Hypertension - Microalbuminuria - Pregnancy - Lactation - Reduced kidney function - Artery stenosis - Kidney transplantation - Allergy to the medication in the study - Reduced liver function - Alcohol or drug abuse - Participation in another drug or clinical test during last 30 days - Severe diseases i.e. malignancy - Previously enrolment of the present study
|Official title||Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB|
|Principal investigator||Nina ES Perrin, PhD-student|
|Description||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.|
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