Effects of Lovastatin on Proteinuria of Diabetic Nephropathy

Phase 2

• Conditions: N08.3 -E11; Proteinuria of Type 2 Diabetic Nephropathy.; Glomerular disorders in diabetes mellitus

• Registration Number: IRCT2012073010446N1
• Lead Sponsor: Drug Applied Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Men with clinically documented T2DN were enrolled. To eliminate potential confounding factors, we only included patients with type 2 diabetes mellitus and proteinuria levels lower than the nephrotic range (i.e., < 3 g/d) whose estimated glomerular filtration rate (eGFR) was higher than 30 mL/min/1.73m2 (as calculated by the Modification of Diet in Renal Disease formula).
The fasting plasma glucose (FPG) of the participants was controlled by insulin injection and/or administration of oral sulfonylurea. Blood pressure (BP) was maintained at less than 129/79 mm Hg with treatment by angiotensin-converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB), with a-blockers and diuretics when needed. All of the patients were under their own regular restricted protein diet (= 0.8 g/kg/d), as prescribed by a nutrition consultant. Any major changes in blood pressure, protein intake, or physical activity during the study period were considered as withdrawal criteria. Exclusion criteria included: the use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) antagonists, fibrates, aspirin, ß-blockers, allopurinol, vitamins, pentoxifylline, fish oil, other antioxidant drugs consumed in the previous three months, active smoking, chronic inflammation (such as diabetic foot, hepatitis, infection, etc.), active coronary artery disease in the previous three months (diagnosed by symptoms and electrocardiography), and poorly controlled diabetes mellitus (Hb-A1c > 7.5%).

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Proteinuria level. Timepoint: (A) before lovastatin therapy (baseline), (B) after 45 days of lovastatin therapy (46th day), (C) after 90 days of lovastatin therapy (91st day), and (D) 30 days after the withdrawal of lovastatin therapy (121st day). Method of measurement: eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula. Twenty-four hour urine samples, Cr, and protein levels were assessed using coulorimetric and immunoturbidimetric methods.