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

Diabetic Nephropathies Clinical Trial

Official title:

Comparative Effects of add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on Serum NT-PRO BNP and Proteinuria in Type 2 Diabetics With Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006952
• Other study ID #: 931133003
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2016
• Last updated: December 29, 2016
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2016
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 38 Years to 76 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Pentoxifylline
pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
• Losartan
losartan arm took 100mg losartan daily for 12 weeks.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months	No
Secondary	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	3 months	No
Secondary	Urinary albumin excretion	Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month	3 months	No
Secondary	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	3 months	No
Secondary	estimated glomerular filtration rate	estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month	3 months	No
Secondary	serum creatinine concentrations	serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month	3 months	No