Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Kitasato University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Tokai University
Yokohama City University Medical Center
St. Marianna University School of Medicine
Information provided by:
Kitasato University
ClinicalTrials.gov Identifier:
NCT00407680
First received: December 4, 2006
Last updated: October 21, 2007
Last verified: October 2007

December 4, 2006
October 21, 2007
October 2006
Not Provided
  • Proteinuria
  • Serum Creatinine
  • e-GFR
  • Fasting Plasma Glucose
  • HbA1c
Same as current
Complete list of historical versions of study NCT00407680 on ClinicalTrials.gov Archive Site
  • Lipid profile
  • Blood pressure
  • Smoking
  • Progression of renal dysfunction
  • Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
  • Serum angiotensinogen
  • Lipid profile
  • Blood pressure
  • Smoking
  • Progression of renal dysfunction
Not Provided
Not Provided
 
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension

To observe the effect of intensive medical treatment for type 2 diabetic patients with hypertension: to discover whether or not intensive medical treatment improves proteinuria, and the difference between the clinical meaning of responder and non-responder (criteria: 50% reduced proteinuria continuing 6 months or more during the observation period.)

It is reported that the risk of a cardiovascular event occurring is 1.78 times higher in patients with diabetic nephropathy (DN) than in patients without DN. It is also reported that angiotensin II receptor blockade (ARB) prevents the progression of DN in diabetic patients with early phase nephropathy beyond its blood pressure lowering effect. The guidelines by the Japanese Society of Hypertension 2004 recommended that it was necessary to control blood pressure (BP) below 130/80 mmHg in all diabetic patients. This has become the universal target BP for the prevention of cardiovascular events in hypertensive patients. On the study of intensive medical treatment [including angiotensin-converting enzyme inhibitor (ACEI)], it is reported that ACEI not only prevents the progression of DN in microalbuminuria but also decreases proteinuria <1 g/day in the nephrotic syndrome. Therefore, ACEI is thought to be effective for DN. However, it is not clear whether or not intensive medical treatment (including ACEI) improves nephropathy with proteinuria >1 g/day.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Hypertension
Drug: Intensive therapy Valsartan,Fluvastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2009
Not Provided

Inclusion Criteria:

Type 2 diabetic patients with hypertension, with all 5 of the criteria listed below:

  1. Age 20 years and above
  2. Blood pressure >125/75 mmHg
  3. Urinary protein creatinine ratio 1g/g・cr or Urinary protein >1 g/day
  4. Presence of diabetic retinopathy
  5. Already performing dietary management

    • There were no limitations on serum creatinine.
    • BP was recorded 3 times while the patient was seated and averaged.
    • The subjects in this study were outpatients with written informed consent.

Exclusion Criteria:

  1. Another definable renal disease other than DN
  2. Collagenosis
  3. Malignant hypertension with emergent treatment
  4. Severe hypertension (diastolic BP >120 mmHg)
  5. Severe chronic heart failure or acute myocardial infarction in the past 6 months
  6. Atrial fibrillation or severe arrhythmia
  7. Anamnesis of cerebrovascular disease with neuropathy
  8. Anamnesis of anaphylaxis or chronic dermatopathy
  9. Severe hepatic disease
  10. Pregnancy
  11. Anamnesis of anaphylaxis from angiotensin II receptor blocker
  12. Patients are judged to be inapposite by the attending physician
Both
20 Years and older
No
Contact: Keiji Tanaka, MD,PhD +81-427-778-8111 ext 8706 keiji@med.kitasato-u.ac.jp
Japan
 
NCT00407680
8417
Not Provided
Not Provided
Kitasato University
  • Tokai University
  • Yokohama City University Medical Center
  • St. Marianna University School of Medicine
Study Chair: Keiji Tanaka, MD,PhD Kitasato University
Kitasato University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP