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

Primary Purpose

Type 2 Diabetes Mellitus, Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Intensive therapy Valsartan,Fluvastatin
Sponsored by
Kitasato University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, Hypertension, Angiotensin II Receptor Blocker, Diabetic nephropathy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kitasato UniversityRecruiting

Outcomes

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

Full Information

First Posted
December 4, 2006
Last Updated
October 21, 2007
Sponsor
Kitasato University
Collaborators
Tokai University, Yokohama City University Medical Center, St. Marianna University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00407680
Brief Title
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
Official Title
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kitasato University
Collaborators
Tokai University, Yokohama City University Medical Center, St. Marianna University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypertension
Keywords
Type 2 diabetes mellitus, Hypertension, Angiotensin II Receptor Blocker, Diabetic nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intensive therapy Valsartan,Fluvastatin
Primary Outcome Measure Information:
Title
Proteinuria
Title
Serum Creatinine
Title
e-GFR
Title
Fasting Plasma Glucose
Title
HbA1c
Secondary Outcome Measure Information:
Title
Lipid profile
Title
Blood pressure
Title
Smoking
Title
Progression of renal dysfunction
Title
Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
Title
Serum angiotensinogen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keiji Tanaka, MD,PhD
Phone
+81-427-778-8111
Ext
8706
Email
keiji@med.kitasato-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keiji Tanaka, MD,PhD
Organizational Affiliation
Kitasato University
Official's Role
Study Chair
Facility Information:
Facility Name
Kitasato University
City
1-15-1 Kitasato Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8111
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keiji Tanaka
Phone
+81-427-8111
Ext
8706
Email
keiji@med.kitasato-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Keiji Tanaka, Keiji Tanaka

12. IPD Sharing Statement

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

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