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| Sponsored by: |
University Hospital Inselspital, Berne |
| Information provided by: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT00384384 |
Purpose
Background: 18B Glycyrrhetinic acid (active compound of Licorice) decreases serum potassium via enhanced renal potassium loss in healthy individuals and thereby inducing renal sodium retention and arterial hypertension.In dialysis patients this mechanism is disturbed and compensatory intestinal potassium secretion is enhanced. 18B Glycyrrhetinic acid is an inhibitor of 11B Hydroxysteroid dehydrogenase type 1 (11b HSD1). Inhibition of 11 b HSD1 offers a novel potential therapy to lower intracellular cortisol concentrations and thereby enhance insulin sensitivity.
Hypothesis: Glycyrrhetinic acid decreases serum potassium by enhanced intestinal excretion in dialysis patients and increases insulin sensivity by inhibition of 11b HSD
Methods: double blind, 6 month cross over trial comparing oral 18b Glycyrrhetinic acid with placebo in 24 nondiabetic dialysis patients.
Endpoints: predialytic serum potassium levels, insuline sensitivity assessed by fasting glucose and fasting insulin concentrations
| Condition | Intervention | Phase |
|
End Stage Renal Disease |
Drug: oral 18B Glycyrrhetinic acid versus placebo |
Phase II |
| MedlinePlus related topics: | High Blood Pressure |
| Drug Information available for: | Insulin Potassium chloride Glycyrrhetinic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients |
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stefan Farese, MD | + 41 31 632 31 44 | stefan.farese@insel.ch |
| Switzerland | |||||
| Department of nephrology and hypertension, University hospital of berne | Recruiting | ||||
| Berne, Switzerland, 3010 | |||||
| Contact: Stefan Farese, MD +41 31 631 31 44 stefan.farese@insel.ch | |||||
| Principal Investigator: Felix J Frey, Prof | |||||
| University Hospital Inselspital, Berne |
| Principal Investigator: | Felix J Frey, Prof | Department of Nephrology and Hypertension, University hospital of Berne |
More Information
| Study ID Numbers: | S51/05 |
| First Received: | October 5, 2006 |
| Last Updated: | October 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00384384 |
| Health Authority: | United States: Food and Drug Administration |
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