Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
This study is currently recruiting participants.
Verified June 2011 by Ajou University School of Medicine
Sponsor:
Ajou University School of Medicine
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Diabetes Mellitus, Type 2 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 May 22, 2013