Clinical trial NCT01382303: Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
Official title: Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
pentoxifylline
proteinuria
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Bundang CHA Hospital
name: Hallym University Medical Center
name: Gangnam Severance Hospital
name: Yonsei University
name: Myongji Hospital
First posted: 2011-06-27
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Percentage Change in Proteinuia
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Percentage Change in Albuminuria
timeFrame: baseline and 24 weeks
measure: Mean Change of eGFR
timeFrame: baseline and 24 weeks
measure: Mean Change of Creatinine
timeFrame: baseline and 24 weeks
measure: Mean Change of Fasting Glucose
timeFrame: baseline and 24 weeks
measure: Mean Change of TNF-a
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Kwan-Woo Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han SJ, Kim HJ, Kim DJ, Sheen SS, Chung CH, Ahn CW, Kim SH, Cho YW, Park SW, Kim SK, Kim CS, Kim KW, Lee KW. Effects of pentoxifylline on proteinuria and glucose control in patients with type 2 diabetes: a prospective randomized double-blind multicenter study. Diabetol Metab Syndr. 2015 Jul 19;7:64. doi: 10.1186/s13098-015-0060-1. eCollection 2015.