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IRCT2012073010446N1 IRCT 2012-08-08 Drug Applied Research Center Effects of Lovastatin on Proteinuria of Diabetic Nephropathy Short-Term Effects of Lovastatin Therapy on Proteinuria of Type 2 Diabetic Nephropathy 2006-02-01 anticipated 30 Complete https://irct.ir/trial/10957 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This was a quasi clinical trial with treatment and withdrawal periods. 2 Proteinuria of Type 2 Diabetic Nephropathy. Lovastatin (Ghazal Co, Tehran, Iran), in a dose of 20 mg/d, was administered to the patients for 90 days. At the end of the third month, the patients were asked to stop lovastatin intake from the 91st day until the 120th day..
public Dr. Nariman Nezami
Clinical Pharmacy Laboratory, Drug Applied Research Center, Tabriz University (Medical Sciences), Pashmineh, Daneshgah Street.
Tabriz Iran (Islamic Republic of) 5165665811 +98 41 1333 8789 dr.nezami@gmail.com Drug Applied Research Center, Tabriz University (Medical Sciences), scientific Dr. Nariman Nezami
Clinical Pharmacy Laboratory, Drug Applied Research Center, Tabriz University (Medical Sciences), Pashmineh, Daneshgah Street,
Tabriz, Iran (Islamic Republic of) 5165665811 +98 41 1333 8789 dr.nezami@gmail.com Drug Applied Research Center, Tabriz University (Medical Sciences) Iran (Islamic Republic of) 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 α-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, β-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%). 40 years 70 years Male N08.3 -E11 Glomerular disorders in diabetes mellitus Treatment - Drugs Lovastatin (Ghazal Co, Tehran, Iran), in a dose of 20 mg/d, was administered to the patients for 90 days. At the end of the third month, the patients were asked to stop lovastatin intake from the 91st day until the 120th day. 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. Drug Applied Research Center Approved 2005-08-23 The Ethics Committee of Tabriz University of Medical Sciences Research Vice of Tabriz University (Medical Sciences), Tabriz University, Tabriz, Iran. Tabriz Iran (Islamic Republic of)