Diabetes, Type I
Conditions
Keywords
Diabetes, Kidney function, 24 ambulatory blood pressure, Kidney biopsy
Brief summary
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
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.
Interventions
DRUGCandesartan
DRUGPlacebo
Sponsors
AstraZeneca
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
17 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Basement membrane thickness | — |
| Mesangial expansion | — |
Secondary
| Measure | Time frame |
|---|---|
| Hypertension | — |
| Microalbuminuria | — |
| Kidney Function | — |
| 24 hour ambulatory blood pressure | — |
Countries
Sweden
Outcome results
None listed