This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Collaborators:
Bundang CHA Hospital
Hallym University Medical Center
Gangnam Severance Hospital
Yonsei University
Myongji Hospital
Information provided by (Responsible Party):
Kwan Woo Lee, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01382303
First received: June 22, 2011
Last updated: March 31, 2017
Last verified: March 2017
  Purpose
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.

Condition Intervention Phase
Type 2 Diabetes Drug: Pentoxifylline Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study

Resource links provided by NLM:


Further study details as provided by Kwan Woo Lee, Ajou University School of Medicine:

Primary Outcome Measures:
  • Percentage Change in Proteinuia [ Time Frame: baseline and 24 weeks ]
    Changes of urine protein to creatinie ratio from baseline to 24 weeks


Secondary Outcome Measures:
  • Percentage Change in Albuminuria [ Time Frame: baseline and 24 weeks ]
    Changes of urine albumin to creatinie ratio from baseline to 24 weeks

  • Mean Change of eGFR [ Time Frame: baseline and 24 weeks ]
    changes in eGFR from baseline to 24 weeks

  • Mean Change of Creatinine [ Time Frame: baseline and 24 weeks ]
    changes serum creatinine from baseline to 24 weeks

  • Mean Change of Fasting Glucose [ Time Frame: baseline and 24 weeks ]
    changes serum fasting glucose from baseline to 24 weeks

  • Mean Change of TNF-a [ Time Frame: baseline and 24 weeks ]
    changes in TNF-a from baseline to 24 weeks


Enrollment: 174
Actual Study Start Date: October 25, 2010
Study Completion Date: December 20, 2013
Primary Completion Date: December 20, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pentoxifylline
Pentoxifylline 400mg three times a day
Drug: Pentoxifylline
Pentoxifylline 400mg three times a day
Other Name: Trental
Placebo Comparator: Placebo
placebo tablet
Drug: Placebo
placebo tablet three times a day

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

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382303

Locations
Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Bundang CHA Hospital
Hallym University Medical Center
Gangnam Severance Hospital
Yonsei University
Myongji Hospital
Investigators
Principal Investigator: Kwan-Woo Lee, PhD Ajou University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kwan Woo Lee, professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01382303     History of Changes
Other Study ID Numbers: AJIRB-MED-CT4-10-055
Study First Received: June 22, 2011
Results First Received: February 13, 2017
Last Updated: March 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kwan Woo Lee, Ajou University School of Medicine:
Type 2 Diabetes
pentoxifylline
proteinuria

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Proteinuria
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on August 17, 2017