Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Pentoxifylline; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pentoxifylline; Pentoxifylline 400mg three times a day	Drug: Pentoxifylline; Pentoxifylline 400mg three times a day; Other Names: Trental
Placebo Comparator: Placebo; placebo tablet	Drug: Placebo; placebo tablet three times a day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: Yonsei University; Gangnam Severance Hospital; Bundang CHA Hospital; Hallym University Medical Center; Myongji Hospital
• Investigators: Principal Investigator: Kwan-Woo Lee, PhD, Ajou University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2010
• Primary Completion (Actual): December 20, 2013
• Study Completion (Actual): December 20, 2013

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: proteinuria; Type 2 Diabetes; pentoxifylline
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Diabetes Mellitus; Urination Disorders; Diabetes Mellitus, Type 2; Proteinuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: AJIRB-MED-CT4-10-055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No