Type 2 DiabetesPhase 1NCT01921881
Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals
A Phase 1 study testing St John's wort in people with Type 2 Diabetes, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- St John's wort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 1
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years
- Males
- Fasting plasma-glucose < 7.0 mmol/L
- Glycosylated haemoglobin A1c within reference or clinically insignificant deviation hereof
- Body mass index < 30 kg/m^2
Who cannot join
- Hypersensitivity to St John's wort
- Chronical or daily alcohol abuse
- Known liver disease
- Ingestion of drugs requiring prescription, except locally acting drugs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark
Odense C, DK-5000
About this study
The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance.
- Conditions
- Type 2 Diabetes
- Being tested
- St John's wort
- Keywords
- Glucose tolerance
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St John's wortOther
| Study group | Role | What they receive |
|---|---|---|
| St John's wort | Experimental | Subjects will undergo 3 oral glucose tolerance tests:
1. Without taking any St John's wort
2. After 3 weeks pretreatment with St John's wort
3. Minimum 6 weeks after last St John's wort ingestion Receives: Other: St John's wort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose area under curve (AUC) 0-2 hours
At time=0, the subjects will ingest 75g glucose. Plasma glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion.
Measured: Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion
Secondary outcomes (2)
St John's wort pharmacokinetics
At time=0, the concentration of active components hypericin and hyperforin will be measured.
Measured: At time=0
Other metabolic markers
C-peptide and serum insulin will also be measured during the oral glucose tolerance test.
Measured: At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tore B. Stage, University of Southern Denmark
- Investigators
- Kim Brøsem, Professor, MD, Study director, University of Southern DenmarkPer Damkier, MD PhD, Principal investigator, University of Southern DenmarkTore B. Stage, MSc Pharm, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921881
- Sponsor's protocol ID
- AKF-385
- Status last verified
- Feb 2015
- First submitted
- 9 Aug 2013
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT01921881
- Acronym / sponsor ID
- AKF-385
- Conditions
- Type 2 Diabetes
- Keywords
- Glucose tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Aug 2013 (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.
The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| St John's wort | Experimental | Other: St John's wortSubjects will undergo 3 oral glucose tolerance tests: 1. Without taking any St John's wort 2. After 3 weeks pretreatment with St John's wort 3. Minimum 6 weeks after last St John's wort ingestion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-40 years
- Males
- Fasting plasma-glucose < 7.0 mmol/L
- Glycosylated haemoglobin A1c within reference or clinically insignificant deviation hereof
- Body mass index < 30 kg/m^2
Key exclusion criteria (4 listed)
- Hypersensitivity to St John's wort
- Chronical or daily alcohol abuse
- Known liver disease
- Ingestion of drugs requiring prescription, except locally acting drugs
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 |
|---|---|---|
| St John's wort | Other | St John's wort |
Primary outcome
Glucose area under curve (AUC) 0-2 hours
Time frame: Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion
At time=0, the subjects will ingest 75g glucose. Plasma glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion.
2 secondary outcomes
St John's wort pharmacokinetics
Time frame: At time=0
Other metabolic markers
Time frame: At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion
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 Feb 2015.
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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.
Kim Brøsem, Professor, MD study director
University of Southern Denmark
Per Damkier, MD PhD principal investigator
University of Southern Denmark
Tore B. Stage, MSc Pharm principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing St John's wort in people with Type 2 Diabetes, run by University of Southern Denmark at 1 site in Denmark.
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 5 inclusion and 4 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 Feb 2015. 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 Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Glucose area under curve (AUC) 0-2 hours (time frame: Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2015.