Hypertension, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, Hypertension, Angiotensin II Receptor Blocker, Diabetic nephropathy
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.)
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.
Interventions
DRUGIntensive therapy Valsartan,Fluvastatin
Sponsors
Tokai University
Yokohama City University Medical Center
St. Marianna University School of Medicine
Kitasato University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proteinuria | — |
| Serum Creatinine | — |
| e-GFR | — |
| Fasting Plasma Glucose | — |
| HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile | — |
| Blood pressure | — |
| Smoking | — |
| Progression of renal dysfunction | — |
| Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin | — |
| Serum angiotensinogen | — |
Countries
Japan
Contacts
Primary ContactKeiji Tanaka, MD,PhD
Outcome results
None listed