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

Condition(s) targeted: Diabetes, Type I

Intervention: Candesartan (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Karolinska University Hospital

Official(s) and/or principal investigator(s):
Nina ES Perrin, PhD-student, Principal Investigator, Affiliation: Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm
Ulla B Berg, Professor, Study Director, Affiliation: Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Basement membrane thickness

Mesangial expansion

Secondary outcome:

Hypertension

Microalbuminuria

Kidney Function

24 hour ambulatory blood pressure

Detailed 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.

Minimum age: 17 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

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

Childrens Hospital, Karolinska University Hospital, Huddinge, Stockholm 141 86, Sweden

Starting date: September 2000
Ending date: April 2006
Last updated: May 18, 2006