Trial record 19 of 99 for:    Open Studies | "Proteinuria"

Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Ajou University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bundang CHA Hospital
Hallym University Medical Center
Gangnam Severance Hospital
Yonsei University
Myongji Hospital
Information provided by:
Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01382303
First received: June 22, 2011
Last updated: June 27, 2011
Last verified: June 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Ajou University School of Medicine:

Primary Outcome Measures:
  • The effects of pentoxifylline on proteinuria in type 2 diabetic patients [ Time Frame: every 12 weeks following radomization, for 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Changes of glucose control status markers [ Time Frame: every 12 weeks following randomization, for 24 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Changes of renal and liver function markers [ Time Frame: Every 12 weeks following randomization, for 24 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Changes of inflammatory markers [ Time Frame: Every 12 weeks following randomization, for 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 162
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (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 Drug: Placebo
placebo tablet three times a day
Other Name: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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

Contacts
Contact: Seung Jin Han, MD 82-31-219-5126 hsj@ajou.ac.kr

Locations
Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Seung Jin Han, md    82-31-219-5126    hsj@ajou.ac.kr   
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

No publications provided

Responsible Party: Seung Jin Han/ Assistant professor of the Department of Endocrinology and Metabolism, Ajou University
ClinicalTrials.gov Identifier: NCT01382303     History of Changes
Other Study ID Numbers: AJIRB-MED-CT4-10-055
Study First Received: June 22, 2011
Last Updated: June 27, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ajou University School of Medicine:
Type 2 Diabetes
pentoxifylline
proteinuria

Additional relevant MeSH terms:
Proteinuria
Diabetes Mellitus, Type 2
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
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on September 18, 2014