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Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients
This study is currently recruiting participants.
Verified by University Hospital Inselspital, Berne, October 2006
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
U.S. FDA Resources
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

Further study details as provided by University Hospital Inselspital, Berne:

Estimated Enrollment: 24
Study Start Date: August 2006
Estimated Study Completion Date: August 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dialysis patients (>3 months)

Exclusion Criteria:

  • diabetics
  • hospital stay in the last 4 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384384

Contacts
Contact: Stefan Farese, MD + 41 31 632 31 44 stefan.farese@insel.ch

Locations
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            
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Felix J Frey, Prof Department of Nephrology and Hypertension, University hospital of Berne
  More Information

Study ID Numbers: S51/05
Study First Received: October 5, 2006
Last Updated: October 5, 2006
ClinicalTrials.gov Identifier: NCT00384384  
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospital Inselspital, Berne:
Dialysis
Serum potassium
18b glycyrrhetinic acid
insulin sensitivity

Study placed in the following topic categories:
Renal Insufficiency
Metabolic Diseases
Glycyrrhetinic Acid
Kidney Failure, Chronic
Insulin
Hyperinsulinism
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009