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Association Between Rosiglitazone Use and Clinical Course of Diabetic Nephropathy: Population-Based Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497666
First Posted: July 9, 2007
Last Update Posted: July 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

Recent data show that Rosiglitazone treatment can reduce proteinuria in diabetic patients. However, currently there are no trials that examine the effects of Rosiglitazone on kidney disease progression, that is, doubling of serum creatinine or time to onset of end-stage renal disease, in patients with diabetic nephropathy.

We decided to study retrospectively the possible association between rosiglitazone use and clinical course of diabetic nephropathy, including rate of deterioration of renal function, appearance and progression of microalbuminuria/proteinuria, survival and acceptance to renal replacement therapy.


Condition Intervention
Diabetes Diabetic Nephropathy Renal Protection Drug: Rosiglitasone (retrospective observation)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: Retrospective Study Evaluating the Association Between Rosiglitazone Use and Clinical Course of Diabetic Nephropathy: Population-Based Study

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Study Start Date: August 2007
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Diagnosis of Diabetes Mellitus Type II
  2. Treatment With Oral hypoglycemics
  3. Availability of Baseline and follow up clinical data

Exclusion Criteria:

  1. Insulin Therapy at baseline
  2. Malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497666


Contacts
Contact: Leonid S Feldman +972-8-9779383 ext 9383 leonidf@asaf.health.gov.il

Locations
Israel
Clalit Health Cervices, Central District Not yet recruiting
Zerifin,, Israel, 70300
Contact: Leonid S Feldman    +972-8-9779383 ext 9383    leonidf@asaf.health.gov.il   
Sub-Investigator: Shlomo Vinker, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Leonid S Feldman Nephrology Division, Assaf Harofeh Medical Center, Zerifin,
Principal Investigator: Leonid S Feldman Assaf-Harofeh Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00497666     History of Changes
Other Study ID Numbers: 346147Rosi
First Submitted: July 6, 2007
First Posted: July 9, 2007
Last Update Posted: July 9, 2007
Last Verified: July 2007

Keywords provided by Assaf-Harofeh Medical Center:
Diabetes
Diabetic nephropathy
renal protection

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs