Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB

Conditions
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Diabetes, Type I

Intervention / Treatment
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* Drug: Candesartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Candesartan|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basement membrane thickness |  |  | 
| Mesangial expansion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension |  |  | 
| Microalbuminuria |  |  | 
| Kidney Function |  |  | 
| 24 hour ambulatory blood pressure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Kidney function, 24 ambulatory blood pressure, Kidney biopsy