Cardiovascular Diseases Clinical Trial
— STADOfficial title:
The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy
Verified date | August 2015 |
Source | Regional Hospital Holstebro |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Men and women - minimum 40 years - Chronic Kidney disease - Estimated GFR (eGFR) between 30 and 90 ml/min - Diabetes Mellitus type II Exclusion Criteria: - Nephrotic Syndrome - Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease - Neoplastic disease - Alcohol abuse, - Drug abuse - Pregnancy or nursing - Blood donation within a month before examination - Hgb < 6,0 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Medicinsk Forskning, Regionshospitalet Holstebro | Holstebro |
Lead Sponsor | Collaborator |
---|---|
Erling Bjerregaard Pedersen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractional excretion of sodium | 5 days treatment | No | |
Secondary | Systolic blood pressure | 5 days | No | |
Secondary | Plasma renin concentration | 5 days | No | |
Secondary | Arterial stiffness | 5 days | No | |
Secondary | Plasma angiotensin II concentration | 5 days | No | |
Secondary | Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC) | 5 days | No | |
Secondary | Augmentations index | 5 days | No |
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