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

NCT00407680 | Unknown Phase 4

• 1 other identifier: 8417
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.)

Conditions

Type 2 Diabetes Mellitus; Hypertension

Keywords

Type 2 diabetes mellitus; Hypertension; Angiotensin II Receptor Blocker; Diabetic nephropathy

Outcome Measures

Primary Outcomes (5)

• Proteinuria

• Serum Creatinine

• e-GFR

• Fasting Plasma Glucose

• HbA1c

Secondary Outcomes (6)

• Lipid profile

• Blood pressure

• Smoking

• Progression of renal dysfunction

• Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin

Interventions

Intensive therapy Valsartan,Fluvastatin DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kitasato University: lead
• Tokai University: collaborator
• Yokohama City University Medical Center: collaborator
• St. Marianna University School of Medicine: collaborator

Study Sites (1)

Kitasato University

1-15-1 Kitasato Sagamihara, Kanagawa, 228-8111, Japan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Diabetic Nephropathies

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Keiji Tanaka, MD,PhD

  Kitasato University

  STUDY CHAIR

Central Study Contacts

Keiji Tanaka, MD,PhD

CONTACT

+81-427-778-8111; keiji@med.kitasato-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: October 1, 2006
• Study Completion: March 1, 2009
• Last Updated: October 23, 2007

Record last verified: 2007-10

Locations

JP (1)