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

Condition(s) targeted: Type 2 Diabetes Mellitus; Hypertension

Intervention: Intensive therapy Valsartan,Fluvastatin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kitasato University

Official(s) and/or principal investigator(s):
Keiji Tanaka, MD,PhD, Study Chair, Affiliation: Kitasato University

Overall contact:
Keiji Tanaka, MD,PhD, Phone: +81-427-778-8111, Ext: 8706, Email: keiji@med.kitasato-u.ac.jp

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.)

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

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

Primary outcome:

Proteinuria

Serum Creatinine

e-GFR

Fasting Plasma Glucose

HbA1c

Secondary outcome:

Lipid profile

Blood pressure

Smoking

Progression of renal dysfunction

Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin

Serum angiotensinogen

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Keiji Tanaka, MD,PhD, Phone: +81-427-778-8111, Ext: 8706, Email: keiji@med.kitasato-u.ac.jp

Kitasato University, 1-15-1 Kitasato Sagamihara, Kanagawa 228-8111, Japan; Recruiting
Keiji Tanaka, Phone: +81-427-8111, Ext: 8706, Email: keiji@med.kitasato-u.ac.jp
Keiji Tanaka, Keiji Tanaka, Principal Investigator

Starting date: October 2006
Ending date: March 2009
Last updated: October 21, 2007