Status:
UNKNOWN
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
Lead Sponsor:
Kitasato University
Collaborating Sponsors:
Tokai University
Yokohama City University Medical Center
Conditions:
Type 2 Diabetes Mellitus
Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 bet...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00407680
Start Date
October 1 2006
End Date
March 1 2009
Last Update
October 23 2007
Active Locations (1)
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1
Kitasato University
1-15-1 Kitasato Sagamihara, Kanagawa, Japan, 228-8111