Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy

Tehran University of Medical Sciences59 enrolled

Overview

This study was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein

Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes patients with nephropathy that might relate to its effect on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein. Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used in type 2 diabetes patients with nephropathy for treatment of diabetes complications. NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Diabetic Nephropathies

Interventions

PentoxifyllineDRUG

pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.

LosartanDRUG

losartan arm took 100mg losartan daily for 12 weeks.

Eligibility

Sex: ALLMin age: 38 YearsMax age: 76 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age\>30 and age\<70, urinary albumin excretion (UAE) ≥150 mg/24 h Exclusion Criteria: * any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/L, glomerular filtration rate (GFR)\<30mL/min/1.73 m and intolerance of pentoxifylline

Locations (1)

Tehran University of Medical Sciences

Tehran, Iran

Outcomes

Primary Outcomes

N terminal brain natriuretic peptide (NT-pro BNP)

N terminal brain natriuretic peptide assessed using ELISA method (zelbio, Germany) with inter- and intra-assay coefficient of variation (CV) \<12% and \<10%. Measured at baseline, 3rd month

Time frame: 3 months

Secondary Outcomes

Highly sensitive C-reactive protein (hsCRP)

Highly sensitive C-reactive protein assessed by commercial kits (DRG kit, Germany) using the ELISA (enzyme-linked immunosorbent assay) method with inter- and intra-assay coefficient of variation (CV) of \<20%. Measured at baseline, 3rd month

Time frame: 3 months

Urinary albumin excretion

Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month

Time frame: 3 months

Blood pressure

Systolic and diastolic blood pressure assessed by mercury sphygnomanometry. Patients were placed in a sitting position and after ten minutes rest, two readings from right-side hand with five minutes interval were obtained. Measured at baseline, 3rd month

Time frame: 3 months

estimated glomerular filtration rate

estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month

Time frame: 3 months

serum creatinine concentrations

serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month

Time frame: 3 months

Data from ClinicalTrials.gov

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