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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00285805 |
Thiazolidinedionederivates (TZD’s) are Peroxisome-Proliferator-Activated-Receptor-γ agonists (PPARγ-agonists) and enhance insulin sensitivity. One of the side effects, however, is the fact that subjects treated with these drugs seem to be more prone to fluid retention. The precise mechanism of rosiglitazone-related fluid retention is unknown, but it is clear that either primary or secondary renal sodium retention is part of the mechanism. Furthermore in observational studies, TZD-related oedema seems to be resistant to loop diuretic therapy. The recent finding that rosiglitazone induces upregulation of the epithelial sodium channel (ENaC) in the kidney could be the explanation for TZD-related fluid retention and the observed resistance to loop diuretics. In the present human in-vivo study the following hypothesis will be tested:
Rosiglitazone treatment stimulates the activity of ENaC in the distal nephron, which enhances the natriuretic effect of amiloride and decreases the natriuretic effect of furosemide in parallel.
Condition | Intervention |
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Insulin Resistance |
Drug: Rosiglitazone versus placebo Drug: response (sodium excretion) to amiloride infusion Drug: response (sodium excretion) to furosemide infusion |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | The Influence of Rosiglitazone on the Diuretic Effect of Furosemide and Amiloride. A Double-Blind Placebo Controlled Cross Over Study. |
Estimated Enrollment: | 12 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | November 2006 |
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Radboud University Nijmegen medical centre | |
Nijmegen, Netherlands, 6500 HB |
Principal Investigator: | Paul Smits, MD, PhD | Radboud University Nijmegen Medical Centre, head of department Pharmacology and Toxicology. |
Principal Investigator: | Cees JJ Tack, MD, PhD | Radboud University Nijmegen Medical Centre, chairman of the departement of diabetology |
Study ID Numbers: | AR-49653-3 |
Study First Received: | February 1, 2006 |
Last Updated: | September 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00285805 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Rosiglitazone Furosemide Amiloride Epithelial sodium channel Sodium excretion |
Hyperinsulinism Metabolic Diseases Amiloride Insulin Resistance |
Metabolic disorder Glucose Metabolism Disorders Furosemide Rosiglitazone |
Membrane Transport Modulators Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Diuretics Sodium Channel Blockers Cardiovascular Agents Sodium Potassium Chloride Symporter Inhibitors Pharmacologic Actions |