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

Phase 4

Completed

• Conditions: Diabetic Nephropathies
• Interventions: Drug: Pentoxifylline; Drug: Losartan

• Registration Number: NCT03006952
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-12
• Study First Submitted: 2016-12-24
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study First Posted: 2016-12-30
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pentoxifylline & losartan	Pentoxifylline	pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
pentoxifylline & losartan	Losartan	pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
Losartan	Losartan	losartan arm took 100mg losartan daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Urinary albumin excretion	3 months	Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month
serum creatinine concentrations	3 months	serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of