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Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, pentoxifylline, proteinuria

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pentoxifylline

Placebo

Arm Description

Pentoxifylline 400mg three times a day

placebo tablet

Outcomes

Primary Outcome Measures

Percentage Change in Proteinuia
Changes of urine protein to creatinie ratio from baseline to 24 weeks

Secondary Outcome Measures

Percentage Change in Albuminuria
Changes of urine albumin to creatinie ratio from baseline to 24 weeks
Mean Change of eGFR
changes in eGFR from baseline to 24 weeks
Mean Change of Creatinine
changes serum creatinine from baseline to 24 weeks
Mean Change of Fasting Glucose
changes serum fasting glucose from baseline to 24 weeks
Mean Change of TNF-a
changes in TNF-a from baseline to 24 weeks

Full Information

First Posted
June 22, 2011
Last Updated
March 31, 2017
Sponsor
Ajou University School of Medicine
Collaborators
Bundang CHA Hospital, Hallym University Medical Center, Gangnam Severance Hospital, Yonsei University, Myongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01382303
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 25, 2010 (Actual)
Primary Completion Date
December 20, 2013 (Actual)
Study Completion Date
December 20, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
Bundang CHA Hospital, Hallym University Medical Center, Gangnam Severance Hospital, Yonsei University, Myongji Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, pentoxifylline, proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentoxifylline
Arm Type
Active Comparator
Arm Description
Pentoxifylline 400mg three times a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablet
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental
Intervention Description
Pentoxifylline 400mg three times a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablet three times a day
Primary Outcome Measure Information:
Title
Percentage Change in Proteinuia
Description
Changes of urine protein to creatinie ratio from baseline to 24 weeks
Time Frame
baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Percentage Change in Albuminuria
Description
Changes of urine albumin to creatinie ratio from baseline to 24 weeks
Time Frame
baseline and 24 weeks
Title
Mean Change of eGFR
Description
changes in eGFR from baseline to 24 weeks
Time Frame
baseline and 24 weeks
Title
Mean Change of Creatinine
Description
changes serum creatinine from baseline to 24 weeks
Time Frame
baseline and 24 weeks
Title
Mean Change of Fasting Glucose
Description
changes serum fasting glucose from baseline to 24 weeks
Time Frame
baseline and 24 weeks
Title
Mean Change of TNF-a
Description
changes in TNF-a from baseline to 24 weeks
Time Frame
baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan-Woo Lee, PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26300986
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.
Results Reference
derived

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Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

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