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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006952
Other study ID # 931133003
Secondary ID
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


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
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