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

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. Identifier: NCT00407680
Recruitment Status : Unknown
Verified October 2007 by Kitasato University.
Recruitment status was:  Recruiting
First Posted : December 5, 2006
Last Update Posted : October 23, 2007
Tokai University
Yokohama City University Medical Center
St. Marianna University School of Medicine
Information provided by:
Kitasato University

Brief Summary:
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.)

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypertension Drug: Intensive therapy Valsartan,Fluvastatin Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
Study Start Date : October 2006
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Primary Outcome Measures :
  1. Proteinuria
  2. Serum Creatinine
  3. e-GFR
  4. Fasting Plasma Glucose
  5. HbA1c

Secondary Outcome Measures :
  1. Lipid profile
  2. Blood pressure
  3. Smoking
  4. Progression of renal dysfunction
  5. Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
  6. Serum angiotensinogen

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00407680

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Contact: Keiji Tanaka, MD,PhD +81-427-778-8111 ext 8706

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Kitasato University Recruiting
1-15-1 Kitasato Sagamihara, Kanagawa, Japan, 228-8111
Contact: Keiji Tanaka    +81-427-8111 ext 8706   
Principal Investigator: Keiji Tanaka, Keiji Tanaka         
Sponsors and Collaborators
Kitasato University
Tokai University
Yokohama City University Medical Center
St. Marianna University School of Medicine
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Study Chair: Keiji Tanaka, MD,PhD Kitasato University

Layout table for additonal information Identifier: NCT00407680    
Other Study ID Numbers: 8417
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: October 2007
Keywords provided by Kitasato University:
Type 2 diabetes mellitus
Angiotensin II Receptor Blocker
Diabetic nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action