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

October 21, 2007 updated by: Kitasato University
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.)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • 1-15-1 Kitasato Sagamihara, Kanagawa, Japan, 228-8111
        • Recruiting
        • Kitasato University
        • Contact:
        • Principal Investigator:
          • Keiji Tanaka, Keiji Tanaka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c
Proteinuria
Serum Creatinine
e-GFR
Fasting Plasma Glucose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kitasato University

Collaborators

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

Investigators

  • Study Chair: Keiji Tanaka, MD,PhD, Kitasato University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 5, 2006

Study Record Updates

Last Update Posted (Estimate)

October 23, 2007

Last Update Submitted That Met QC Criteria

October 21, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8417 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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