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

NCT ID: NCT00407680

Last Updated: 2007-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-03-31

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.

Conditions

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Type 2 Diabetes Mellitus Hypertension

Keywords

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Type 2 diabetes mellitus Hypertension Angiotensin II Receptor Blocker Diabetic nephropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Intensive therapy Valsartan,Fluvastatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokai University

OTHER

Sponsor Role collaborator

Yokohama City University Medical Center

OTHER

Sponsor Role collaborator

St. Marianna University School of Medicine

OTHER

Sponsor Role collaborator

Kitasato University

OTHER

Sponsor Role lead

Principal Investigators

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Keiji Tanaka, MD,PhD

Role: STUDY_CHAIR

Kitasato University

Locations

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Kitasato University

1-15-1 Kitasato Sagamihara, Kanagawa, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Keiji Tanaka, MD,PhD

Role: CONTACT

Phone: +81-427-778-8111

Email: [email protected]

Facility Contacts

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Keiji Tanaka

Role: primary

Other Identifiers

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8417

Identifier Type: -

Identifier Source: org_study_id