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

Study Overview
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Brief Summary
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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.)

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes Mellitus, Hypertension

Intervention / Treatment
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* Drug: Intensive therapy Valsartan,Fluvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients with hypertension, with all 5 of the criteria listed below: Age 20 years and above Blood pressure >125/75 mmHg Urinary protein creatinine ratio 1g/g・cr or Urinary protein >1 g/day Presence of diabetic retinopathy 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: Another definable renal disease other than DN Collagenosis Malignant hypertension with emergent treatment Severe hypertension (diastolic BP >120 mmHg) Severe chronic heart failure or acute myocardial infarction in the past 6 months Atrial fibrillation or severe arrhythmia Anamnesis of cerebrovascular disease with neuropathy Anamnesis of anaphylaxis or chronic dermatopathy Severe hepatic disease Pregnancy Anamnesis of anaphylaxis from angiotensin II receptor blocker Patients are judged to be inapposite by the attending physician

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intensive therapy Valsartan,Fluvastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteinuria |  |  | 
| Serum Creatinine |  |  | 
| e-GFR |  |  | 
| Fasting Plasma Glucose |  |  | 
| HbA1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile |  |  | 
| Blood pressure |  |  | 
| Smoking |  |  | 
| Progression of renal dysfunction |  |  | 
| Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin |  |  | 
| Serum angiotensinogen |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Hypertension, Angiotensin II Receptor Blocker, Diabetic nephropathy