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

NCT ID: NCT03006952

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Diabetic Nephropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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pentoxifylline & losartan

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

Group Type ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type DRUG

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

Losartan

Intervention Type DRUG

losartan arm took 100mg losartan daily for 12 weeks.

Losartan

losartan arm took 100mg losartan daily for 12 weeks.

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

losartan arm took 100mg losartan daily for 12 weeks.

Interventions

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Pentoxifylline

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

Intervention Type DRUG

Losartan

losartan arm took 100mg losartan daily for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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oxpentifylline Cozaar

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alireza Esteghamati, MD

Role: STUDY_CHAIR

Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran

Locations

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Tehran University of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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931133003

Identifier Type: -

Identifier Source: org_study_id