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

• Status: Unknown status
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kitasato University
• Collaborators: St. Marianna University School of Medicine; Tokai University; Yokohama City University Medical Center
• Treatments: Fluvastatin; Valsartan

Criteria

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