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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2007 by Kitasato University.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Tokai University

Yokohama City University Medical Center

St. Marianna University School of Medicine

Information provided by:

Kitasato University

ClinicalTrials.gov Identifier:

NCT00407680

First received: December 4, 2006

Last updated: October 21, 2007

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 4, 2006

Last Updated Date

October 21, 2007

Start Date ^ICMJE

October 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Proteinuria
Serum Creatinine
e-GFR
Fasting Plasma Glucose
HbA1c

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00407680 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Lipid profile
Blood pressure
Smoking
Progression of renal dysfunction
Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
Serum angiotensinogen

Original Secondary Outcome Measures ^ICMJE

Lipid profile
Blood pressure
Smoking
Progression of renal dysfunction

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus
Hypertension

Intervention ^ICMJE

Drug: Intensive therapy Valsartan,Fluvastatin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Keiji Tanaka, MD,PhD

+81-427-778-8111 ext 8706

keiji@med.kitasato-u.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00407680

Other Study ID Numbers ^ICMJE

8417

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Kitasato University

Collaborators ^ICMJE

Tokai University
Yokohama City University Medical Center
St. Marianna University School of Medicine

Investigators ^ICMJE

Study Chair:

Keiji Tanaka, MD,PhD

Kitasato University

Information Provided By

Kitasato University

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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