Protection Against Nephropathy in Diabetes with Atorvastati

Not Applicable

Completed

• Conditions: Type II diabetes with proteinuria; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN58196433
• Lead Sponsor: niversity of Manchester (UK)

Brief Summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21166851 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29246729 (added 23/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-21
• Study Completion: 2008-06-30
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

1. Type 2 diabetes (defined according to the World Health Organization criteria) previously known to have proteinuria or microalbuminuria
2. Urinary albumin:creatinine ratio greater than 5 mg/mmol on two consecutive urine samples
3. Aged over 40
4. Capable of giving informed consent
5. Consent to inform General Practitioner of inclusion in study

Exclusion Criteria

1. Urinary protein output >2g/24 hours
2. Serum creatinine >= 200 µmol/l
3. Blood pressure >160/90 mmHg at randomisation
4. Women of child bearing potential
5. Serum cholesterol >= 7 mmol/l or fasting serum triglycerides >= 6 mmol/l at any visit
6. Taking >10 mg of atorvastatin at screening
7. Untreated hypothyroidism
8. Hepatic dysfunction, transaminase >2 times the upper limit of normal or alkaline phosphatase >1.5 times the upper limit of normal
9. Any other concomitant illness other than diabetes or its complication likely to effect outcome
10. Concomitant medication that may interact adversely with HMG-CoA reductase inhibitors or ATII receptor antagonists
11. Known intolerance of ATII receptor antagonists or HMG-CoA reductase inhibitors
12. HbA1c >10% at randomisation
13. Current participation in another clinical trial
14. Unable to comply with protocol for other reasons
15. Other lipid lowering medication at randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Difference in the mean level of glomerular filtration rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily<br> 2. Difference in the mean level of albumin excretion rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily<br>