Status:
COMPLETED
Nitric Oxide (NO) Activity and Diabetic Nephropathy
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Experimental data suggest that oxidative stress and endothelial dysfunction are key players in the pathogenesis of diabetic nephropathy. In the last few years the investigators were able to establish ...
Eligibility Criteria
Inclusion
- Male and female patients aged 18-65 with diabetes, prediabetes or metabolic syndrome
- Male and female healthy control subjects aged 18-65
Exclusion
- Advanced damage of vital organs (grade III and IV retinopathy)
- Therapy with a not approved concomitant medication in the last 4 weeks prior to intake of the first trial medication, especially lipid lowering and antidiabetic medications (washout phase)
- Blood donation within the last 4 weeks
- Patients with arterial fibrillation or atrioventricular (AV)-block (II and more)
- Patients with anamnestic myocardial infarct
- Patients with depression
- Patients with seizure disorders
- Patients with unstable angina pectoris including electrocardiogram (ECG)-aberrations or cardiac insufficiency New York Heart Association (NYHA) Stadium III and IV
- History of a malignant illness with the exception of those patients who have recovered for more than 10 years or have a basalioma of the skin.
- Actual or anamnestic alcohol or drug abuse
- History of organ transplant
- Anaphylaxis or known therapy resistance to any of the used test matters.
- Therapy with a not approved concomitant therapy
- Participation in another study within three months prior to study inclusion
- Illnesses, which can influence the pharmacodynamics or pharmacokinetics of the test substance
- Liver or kidney diseases; SGOT, GPT, γ-GT, AP, bilirubin and creatinine above 200% of standard
- Patients who are not sufficiently compliant, or patients who are not capable or willing to appear for controlling visits
- Severe or unstable medical or psychiatric illnesses, which will, in the estimation of the examiner, endanger the safety of the proband or the successful participation in the study
- Presumed risk of transmission of HIV or hepatitis via blood from the proband
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00136188
Start Date
August 1 2009
End Date
December 1 2011
Last Update
June 19 2012
Active Locations (1)
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1
CRC, Medizinische Klnik 4 - Nephrology and Hypertension, Uni Erlangen-Nürnberg
Erlangen, Germany, 91054