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

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

oral 18B Glycyrrhetinic acid versus placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Dialysis, Serum potassium, 18b glycyrrhetinic acid, insulin sensitivity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

dialysis patients (>3 months)

Exclusion Criteria:

diabetics
hospital stay in the last 4 weeks

Sites / Locations

Department of nephrology and hypertension, University hospital of berne

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00384384

First Posted

October 5, 2006

Last Updated

January 12, 2011

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT00384384

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

Dialysis, Serum potassium, 18b glycyrrhetinic acid, insulin sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

oral 18B Glycyrrhetinic acid versus placebo

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: dialysis patients (>3 months) Exclusion Criteria: diabetics hospital stay in the last 4 weeks

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix J Frey, Prof

Organizational Affiliation

Department of Nephrology and Hypertension, University hospital of Berne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of nephrology and hypertension, University hospital of berne

City

Berne

ZIP/Postal Code

3010

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

19641483

Citation

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. doi: 10.1038/ki.2009.269. Epub 2009 Jul 29.

Results Reference

derived

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

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