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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00407680
• Other study ID #: 8417
• Status: Recruiting
• Phase: Phase 4
• First received: December 4, 2006
• Last updated: October 21, 2007
• Start date: October 2006
• Est. completion date: March 2009

Study information

• Verified date: October 2007
• Source: Kitasato University
• Contact: Keiji Tanaka, MD,PhD
• Phone: +81-427-778-8111
• Email: keiji[@]med.kitasato-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Kidney Diseases
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Intensive therapy Valsartan,Fluvastatin

Locations

Country	Name	City	State
Japan	Kitasato University	1-15-1 Kitasato Sagamihara	Kanagawa

Sponsors (4)

Lead Sponsor	Collaborator
Kitasato University	St. Marianna University School of Medicine, Tokai University, Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteinuria
Primary	Serum Creatinine
Primary	e-GFR
Primary	Fasting Plasma Glucose
Primary	HbA1c
Secondary	Lipid profile
Secondary	Blood pressure
Secondary	Smoking
Secondary	Progression of renal dysfunction
Secondary	Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
Secondary	Serum angiotensinogen