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

First Received on December 4, 2006. Last Updated on October 21, 2007 History of Changes

Sponsor:	Kitasato University
Collaborators:	Tokai University Yokohama City University Medical Center St. Marianna University School of Medicine
Information provided by:	Kitasato University
ClinicalTrials.gov Identifier:	NCT00407680

Purpose

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.)

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Hypertension	Drug: Intensive therapy Valsartan,Fluvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 High Blood Pressure

Drug Information available for: Fluvastatin Valsartan

U.S. FDA Resources

Further study details as provided by Kitasato University:

Primary Outcome Measures:

Proteinuria
Serum Creatinine
e-GFR
Fasting Plasma Glucose
HbA1c

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	October 2006
Estimated Study Completion Date:	March 2009

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407680

Contacts

Contact: Keiji Tanaka, MD,PhD

+81-427-778-8111 ext 8706

keiji@med.kitasato-u.ac.jp

Locations

Japan
Kitasato University	Recruiting
1-15-1 Kitasato Sagamihara, Kanagawa, Japan, 228-8111
Contact: Keiji Tanaka +81-427-8111 ext 8706 keiji@med.kitasato-u.ac.jp
Principal Investigator: Keiji Tanaka, Keiji Tanaka

Sponsors and Collaborators

Kitasato University

Tokai University

Yokohama City University Medical Center

St. Marianna University School of Medicine

Investigators

Study Chair:

Keiji Tanaka, MD,PhD

Kitasato University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00407680 History of Changes
Other Study ID Numbers:	8417
Study First Received:	December 4, 2006
Last Updated:	October 21, 2007
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kitasato University:

Type 2 diabetes mellitus
Hypertension
Angiotensin II Receptor Blocker
Diabetic nephropathy

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Fluvastatin
Valsartan
Angiotensin Receptor Antagonists

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012