Status:
COMPLETED
Renin Angiotensin System Study (RASS/B-RASS)
Lead Sponsor:
Michael Mauer, MD
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Merck Sharp & Dohme LLC
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
16-61 years
Phase:
PHASE2
Brief Summary
To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.
Detailed Description
The primary objective of this research is to determine, in type 1 (insulin-dependent) diabetic patients without hypertension, diabetic nephropathy (DN), or levels of microalbuminuria (MA) predictive o...
Eligibility Criteria
Inclusion
- type 1 diabetic (DM) for 2-20 yrs
- type 1 DM onset prior to 45; if onset was between ages 31-41, BMI \<26; onset 41-45, positive GAD or ICA required
- normal or increased GFR
- normal BP
- normoalbuminuric (\<20 ug/min on 2 of 3 time overnight urine collections)
Exclusion
- type 1 DM duration longer than 20 yrs
- hypertension (\>85/135 mmHg)
- reduced GFR (\<90 ml/min/1.73m2)
- microalbuminuria
- solitary kidney or evidence of unilateral renal disease
- evidence of other important kidney disease by history, ultrasound or biopsy
- other chronic diseases or conditions such as cystic fibrosis, serious mental illness, severe mental retardation, etc.
- pregnancy or females planning pregnancy within 2 years were excluded due to the drugs being used
- compliance (pt not taking at least 85% of two week placebo were excluded)
Key Trial Info
Start Date :
March 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00143949
Start Date
March 1 1997
End Date
May 1 2008
Last Update
November 6 2008
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Mt Sinai Hospital, University of Toronto (Clinical Ctr)
Toronto, Ontario, Canada, M5G 1X5
2
Royal Victoria Hospital, McGill University (Data Center)
Montreal, Quebec, Canada, H3A 1A1
3
Montreal Childrens Hospital, McGill University (Clinical Ctr)
Montreal, Quebec, Canada, H3H 1P3