End Stage Renal DiseasePhase 2NCT00384384
Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients
A Phase 2 study of End Stage Renal Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2006to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- dialysis patients (>3 months)
Who cannot join
- diabetics
- hospital stay in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of nephrology and hypertension, University hospital of berne
Bern, 3010
About this study
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
Read more
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
- Conditions
- End Stage Renal Disease
- Being tested
- oral 18B Glycyrrhetinic acid versus placebo
- Keywords
- Dialysis, Serum potassium, 18b glycyrrhetinic acid, insulin sensitivity
- Medical subject headings
- Kidney Failure, Chronic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral 18B Glycyrrhetinic acid versus placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startAug 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Felix J Frey, Prof, Principal investigator, Department of Nephrology and Hypertension, University hospital of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384384
- Sponsor's protocol ID
- S51/05
- Status last verified
- Jan 2011
- First submitted
- 5 Oct 2006
- Last updated
- 13 Jan 2011
- Results posted
- No
Publications
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.
PubMed 19641483
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00384384
- Acronym / sponsor ID
- S51/05
- Conditions
- End Stage Renal Disease
- Keywords
- Dialysis, Serum potassium, 18b glycyrrhetinic acid, insulin sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- dialysis patients (>3 months)
Key exclusion criteria (2 listed)
- diabetics
- hospital stay in the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral 18B Glycyrrhetinic acid versus placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
- Derived from this study: PubMed 19641483Farese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix J Frey, Prof principal investigator
Department of Nephrology and Hypertension, University hospital of Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of End Stage Renal Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2011.