Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01382303
• Other study ID #: AJIRB-MED-CT4-10-055
• Status: Recruiting
• Phase: Phase 4
• First received: June 22, 2011
• Last updated: June 27, 2011
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: June 2011
• Source: Ajou University School of Medicine
• Contact: Seung Jin Han, MD
• Phone: 82-31-219-5126
• Email: hsj[@]ajou.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Proteinuria
• Type 2 Diabetes

Intervention

Drug:
• Pentoxifylline
Pentoxifylline 400mg three times a day
• Placebo
placebo tablet three times a day

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (6)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Bundang CHA Hospital, Gangnam Severance Hospital, Hallym University Medical Center, Myongji Hospital, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of pentoxifylline on proteinuria in type 2 diabetic patients	Spont urine will be collected at baseline, 12 weeks and 24 weeks after randomization. Changes of urine protein to creatinie and urine albumin to creatinine ratio (mg/g) from baseline will be compared between the active group and placebo group. Estimated glomerular filtration rate (GFR) will be also calculated.	every 12 weeks following radomization, for 24 weeks	Yes
Secondary	Changes of glucose control status markers	Glucose control status markers such as fasting glucose (mg/dL), hemoglobin A1c (%), insulin (uU/mL) will be checked at baseline, 12 weeks and 24 weeks after randomization. The changes of above markers will be compared between the active group and placebo group.	every 12 weeks following randomization, for 24 weeks	Yes
Secondary	Changes of renal and liver function markers	Various markers that represent the function of kidney and liver will be checked at baseline, 12 weeks and 24 weeks after randomization. The markers are serum creatinine (mg/dL), aspartate aminotransferase/alanine aminotransferase/gamma-glutamyltransferase (IU/L), uric acid (mg/dL). The changes of above markers will be compared between the active group and placebo group.	Every 12 weeks following randomization, for 24 weeks	Yes
Secondary	Changes of inflammatory markers	Inflammatory markers such as tumor necrosis factor-alpha (pg/mL) or C-reactive protein (mg/mL) will be checked at baseline, 12 weeks and 24 weeks after randomization. The changes of above markers will be compared between the active group and placebo group.	Every 12 weeks following randomization, for 24 weeks	Yes