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Sponsored by: |
University of Erlangen-Nürnberg |
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Information provided by: | University of Erlangen-Nürnberg |
ClinicalTrials.gov Identifier: | NCT00452192 |
A major complication of diabetes mellitus is diabetic nephropathy. In previous studies we could demonstrate that in patients with type 2 diabetes mellitus despite unaltered basal and stimulated NO-activity, the renal response to the antioxidant vitamin C was more pronounced compared to control subjects. These data suggest that oxidative stress is increased in the renal vasculature of diabetic patients. Furthermore, NO-activity in diabetic patients appears to be up regulated to compensate for increase in oxidative stress. This hypothesis is supported by the demonstration of increased endothelial nitric oxide synthase (eNOS) expression in kidney biopsies of diabetic patients.
Angiotensin receptor blockers have been found to reduce oxidative stress in various vascular beds. Some drugs of this class, Telmisartan for example, also exhibit partial agonist properties to the PPARγ receptor and might be of great benefit for patients with diabetes mellitus or metabolic syndrome due to an additional improvement in insulin resistance. Despite its effect on oxidative stress angiotensin receptor blockers beneficially alter renal haemodynamics by reducing intraglomerular pressure and thus protect against glomerular injury.
Recent advances in magnetic resonance imaging lead to the development of new techniques that allow a separate measurement of renal medullar and cortical perfusion. This magnetic resonance imaging technique might be a useful tool to detect alterations at an early level in the kidneys of patients at high risk for diabetic nephropathy. In the current study we want to evaluate the new magnetic resonance imaging technique by measuring medullar and cortical renal perfusion before and after pharmacological intervention with telmisartan in patients with metabolic syndrome.
Condition | Intervention | Phase |
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Metabolic Syndrome |
Drug: Telmisartan |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Detailed Analysis of the Effects of Telmisartan on Renal Perfusion in Patients With Metabolic Syndrome |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with at least 3 of 5 criteria of the metabolic syndrome:
Exclusion Criteria:
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
Contact: Roland E Schmieder, MD | 0049(0)91318536245 | Roland.Schmieder@rzmail.uni-erlangen.de |
Contact: Martin Ritt, MD | 0049(0)91318536218 | Martin.Ritt@med4.imed.uni-erlangen.de |
Germany | |
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg | Recruiting |
Erlangen, Germany, 91054 | |
Contact: Roland E Schmieder, MD 0049(0)91318536245 Roland.Schmieder@rzmail.uni-erlangen.de | |
Contact: Martin Ritt, MD 0049(0)91318536218 Martin.Ritt@med4.imed.uni-erlangen.de | |
Principal Investigator: Roland E Schmieder, MD | |
Sub-Investigator: Martin Ritt, MD |
Principal Investigator: | Roland. E Schmieder, MD | Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg |
Study ID Numbers: | SFB 423-TP B5 Niere MRT |
Study First Received: | March 26, 2007 |
Last Updated: | March 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00452192 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Telmisartan Angiotensin II |
Angiotensin II Type 1 Receptor Blockers Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Syndrome |
Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |