Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
Information source: Ajou University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Pentoxifylline (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ajou University School of Medicine Official(s) and/or principal investigator(s): Kwan-Woo Lee, PhD, Principal Investigator, Affiliation: Ajou University School of Medicine
Overall contact: Seung Jin Han, MD, Phone: 82-31-219-5126, Email: hsj@ajou.ac.kr
Summary
This multi-center, randomized controlled study aims to evaluate the effects of
pentoxifylline on proteinuria in Korean type 2 diabetic patients.
Clinical Details
Official title: Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: The effects of pentoxifylline on proteinuria in type 2 diabetic patients
Secondary outcome: Changes of glucose control status markersChanges of renal and liver function markers Changes of inflammatory markers
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Seung Jin Han, MD, Phone: 82-31-219-5126, Email: hsj@ajou.ac.kr
Ajou University Hospital, Suwon, Korea, Republic of; Recruiting Seung Jin Han, md, Phone: 82-31-219-5126, Email: hsj@ajou.ac.kr
Additional Information
Starting date: September 2010
Last updated: June 27, 2011
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