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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 markers

Changes 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

Page last updated: August 23, 2015

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