Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Dialysis High Blood Pressure Kidney Failure Potassium

Drug Information available for: Insulin Insulin beef Glycyrrhetinic acid Potassium chloride

U.S. FDA Resources

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

Estimated Enrollment:	24
Study Start Date:	August 2006
Study Completion Date:	April 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

Locations

Switzerland
Department of nephrology and hypertension, University hospital of berne
Berne, Switzerland, 3010

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

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Farese S, Kruse A, Pasch A, Dick B, Frey BM, Uehlinger DE, Frey FJ. Glycyrrhetinic acid food supplementation lowers serum potassium concentration in chronic hemodialysis patients. Kidney Int. 2009 Oct;76(8):877-84. Epub 2009 Jul 29.

ClinicalTrials.gov Identifier:	NCT00384384 History of Changes
Other Study ID Numbers:	S51/05
Study First Received:	October 5, 2006
Last Updated:	January 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University Hospital Inselspital, Berne:

Dialysis
Serum potassium
18b glycyrrhetinic acid
insulin sensitivity

Additional relevant MeSH terms:

Insulin Resistance
Kidney Diseases
Kidney Failure, Chronic
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic

Renal Insufficiency
Glycyrrhetinic Acid
Insulin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012