Diabetic Nephropathies
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGPentoxifylline
pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
DRUGLosartan
losartan arm took 100mg losartan daily for 12 weeks.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
38 Years to 76 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| N terminal brain natriuretic peptide (NT-pro BNP) | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Highly sensitive C-reactive protein (hsCRP) | 3 months | 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 |
| Urinary albumin excretion | 3 months | Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month |
| Blood pressure | 3 months | 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 |
| estimated glomerular filtration rate | 3 months | estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month |
| serum creatinine concentrations | 3 months | serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month |
Countries
Iran
Outcome results
None listed