Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

Study Overview
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Brief Summary
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This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.

Detailed Description
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The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements. Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks. Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks. The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.

Official Title
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Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Pentoxifylline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus age >=20 years spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements patients on ACE-inhibitor or ARB as an anti-hypertensive drug blood pressure <= 150/100 mmHg HbA1c <10% Exclusion Criteria: taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months ischemic heart disease, stroke, malignant disease, severe infection in 6 months serum creatinine > 2.0mg/dl severe liver disease or AST, ALT > 3* ULM taking systemic steroid in 1 month pregnant or plan to become pregnant during the clinical trial lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pentoxifylline<br>Pentoxifylline 400mg three times a day | Drug: Pentoxifylline<br>* Pentoxifylline 400mg three times a day<br>* Other names: Trental;|
| Placebo Comparator: Placebo<br>placebo tablet | Drug: Placebo<br>* placebo tablet three times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Proteinuia | Changes of urine protein to creatinie ratio from baseline to 24 weeks | baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Albuminuria | Changes of urine albumin to creatinie ratio from baseline to 24 weeks | baseline and 24 weeks | 
| Mean Change of eGFR | changes in eGFR from baseline to 24 weeks | baseline and 24 weeks | 
| Mean Change of Creatinine | changes serum creatinine from baseline to 24 weeks | baseline and 24 weeks | 
| Mean Change of Fasting Glucose | changes serum fasting glucose from baseline to 24 weeks | baseline and 24 weeks | 
| Mean Change of TNF-a | changes in TNF-a from baseline to 24 weeks | baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, pentoxifylline, proteinuria