Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/07/2004
Date assigned
22/07/2004
Last edited
09/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bernard Zinman

ORCID ID

Contact details

Leadership Sinai Centre for Diabetes
Lebovic Building
5th Floor
L5-024
Mount Sinai Hospital
600 University Avenue
Toronto
ON
M5G 1X5
Canada
+1 416 586 8747
zinman@mshri.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DCT-14281

Study information

Scientific title

Acronym

RASS

Study hypothesis

Inhibition of the renin angiotensin system will protect the kidney.

Ethics approval

Approval received from the Mount Sinai research ethics board

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetic Nephropathy (DN)

Intervention

1. Angiotensin-Converting Enzyme (ACE) inhibitor: Enalapril
2. Angiotensin Receptor Blocker: Losarten

Intervention type

Drug

Phase

Not Specified

Drug names

Enalapril, Losarten

Primary outcome measures

The primary outcome is to determine, in Type one diabetes without clinical evidence of diabetic nephropathy, if inhibition of the renin-angiotensin system activity can prevent or retard the rate of development of the histologic lesions associated with diabetic nephropathy.

Secondary outcome measures

1. Retinopathy
2. Microalbuminuria
3. Blood pressure
4. GFR
5. Creatinine

Overall trial start date

01/03/1997

Overall trial end date

01/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with type one diabetes
2. Normal Glomerular Filtration Rate (GFR) and Blood Pressure (BP)
3. Normoalbuminuria
4. Either sex, 18 to 64 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

285

Participant exclusion criteria

1. Type one Diabetes Mellitus longer then 20 years
2. BP more than 135/85 mmHg
3. GFR less than 90 ml/min
4. Microalbuminuria
5. Soiltary kidney
6. Other chronic disease
7. Pregnancy or planning pregnancy within two years of randomisation

Recruitment start date

01/03/1997

Recruitment end date

01/03/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Leadership Sinai Centre for Diabetes
Toronto, ON
M5G 1X5
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa
ON
K1A OW9
Canada
+1 888 603 4178
info@cihr-irsc.gc.ca

Sponsor type

Research organisation

Website

http://www.cihr-irsc.gc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-14281)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Merck Frosst Canada & Co (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes