Official Title: “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.)

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Intensive therapy Valsartan,Fluvastatin

Primary Measures

• Proteinuria
• Serum Creatinine
• e-GFR
• Fasting Plasma Glucose
• HbA1c

Secondary Measures

• Lipid profile
• Blood pressure
• Smoking
• Progression of renal dysfunction
• Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
• Serum angiotensinogen

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kitasato University

Overall Clinical Trial Officials and Contacts

Keiji Tanaka, MD,PhD Study Chair Kitasato University  

Overall Contact: Keiji Tanaka, MD,PhD +81-427-778-8111 keiji@med.kitasato-u.ac.jp

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00407680

Study ID Number: 8417

ClinicalTrials.gov Identifier: NCT00407680

Health Authority: Japan: Ministry of Health, Labor and Welfare