Clinical trial NCT00407680: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Hypertension
Keywords: Type 2 diabetes mellitus
Hypertension
Angiotensin II Receptor Blocker
Diabetic nephropathy
Lead sponsor: Kitasato University
Sponsor class: OTHER
Collaborators: name: Tokai University
name: Yokohama City University Medical Center
name: St. Marianna University School of Medicine
First posted: 2006-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proteinuria
measure: Serum Creatinine
measure: e-GFR
measure: Fasting Plasma Glucose
measure: HbA1c
Secondary outcomes:
measure: Lipid profile
measure: Blood pressure
measure: Smoking
measure: Progression of renal dysfunction
measure: Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
measure: Serum angiotensinogen
Other outcomes:
Locations:
city: 1-15-1 Kitasato Sagamihara
country: Japan
facility: Kitasato University
state: Kanagawa
Study officials:
affiliation: Kitasato University
name: Keiji Tanaka, MD,PhD
role: STUDY_CHAIR
References: