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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Kitasato University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407680
First Posted: December 5, 2006
Last Update Posted: October 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tokai University
Yokohama City University Medical Center
St. Marianna University School of Medicine
Information provided by:
Kitasato University
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension

Resource links provided by NLM:


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

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00407680     History of Changes
Other Study ID Numbers: 8417
First Submitted: December 4, 2006
First Posted: December 5, 2006
Last Update Posted: October 23, 2007
Last Verified: October 2007

Keywords provided by Kitasato University:
Type 2 diabetes mellitus
Hypertension
Angiotensin II Receptor Blocker
Diabetic nephropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Valsartan
Fluvastatin
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors