Healthy SubjectsNCT01934816
Incretin and KATP Channels
A study testing Intradermal injections of GLP-1 and its analogues in people with Healthy Subjects, run by Katarina Kos at 1 site in United Kingdom.
Trial summary
This study aims to examine the involvement of KATP channels on the microvascular actions of the incretin GLP-1 and its analogues in healthy individuals and to determine whether the acute oral administration of different KATP channel blockers which are oral medications for Type 2 diabetes such as Glibenclamide and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Intradermal injections of GLP-1 and its analogues
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Oct 2015
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≤ 25 kg/m2
Who cannot join
- current or past history of diabetes (HbA1C more or equal 45mmol/mol)
- history of postprandial hypoglycaemia and dumping syndrome
- established cardiovascular disease
- established cerebrovascular disease
- blood pressure ≥ 140/85 mmHg
- Raynaud's disease
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- severe impairment of renalhepatic, thyroid or adrenocortical function
- current treatment with any anti-hypertensive treatment
- lipid lowering therapy or systemic steroids
- lactation, pregnancy
- established vascular disease
- bariatric surgery
- significant weight change within the last 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX25DW
About this study
Official title: Effects of KATP Channel Blockers on GLP-1 and Its Analogues' Mediated Microvascular Function
This study aims to examine the involvement of KATP channels on the microvascular actions of the incretin GLP-1 and its analogues in healthy individuals and to determine whether the acute oral administration of different KATP channel blockers which are oral medications for Type 2 diabetes such as Glibenclamide and Glimepiride differentially modulate the microvascular responses in these individuals.
Read the detailed description
In addition to the glucose lowering effect, incretin based therapies have also an effect on the vascular system. Previous animal work and initial human studies suggest that incretins may be cardioprotective and act as vasodilators through opening of KATP channels.
Initial evidence suggests that beneficial vascular effects of incretin modifying agents may be nullified by the co-current treatment of the sulfonylurea (SU) drug glibenclamide. The investigators hypothesis is that the GLP-1 and SUs may have conflicting effects on the KATP channels and thus vascular function.
Interestingly the vascular actions of GLP-1 were not modified by a different treatment SUs called glimepiride, thereby raising the possibility that SUs differentially modulating the vascular actions of GLP-1 though this remains controversial.
- Conditions
- Healthy Subjects
- Being tested
- Intradermal injections of GLP-1 and its analogues
- Keywords
- Incretins, KATP channels, intradermal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injections of GLP-1 and its analoguesOther
Also called microinjection of GLP-1 (native GLP-1), and its analogues such as Exenatide(Byetta), and Liraglutide (Victoza)
native GLP-1,Exenatide (Byetta)and Liraglutide (Victoza) will be microinjected at the same visit in no particular order in all study arms
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride | Experimental | 4mg of Glimepiride once only before vascular testing and intradermal injections of GLP-1 and its analogues Receives: Other: Intradermal injections of GLP-1 and its analogues |
| Placebo tablet | Placebo comparator | Placebo tablet is given in the morning of the intradermal injections of GLP-1 and its analogues Receives: Other: Intradermal injections of GLP-1 and its analogues |
| Glyburide | Active comparator | 10mg of Glyburide before study visit and intradermal injections of GLP-1 and its analogues Receives: Other: Intradermal injections of GLP-1 and its analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin blood flow to GLP-1 and its analogues
Skin blood flow will be assessed before and after microinjection of GLP-1 or its analogues and the injection site monitored and compared to sites injected with placebo
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2015
- Study completionOct 2015
Why it stopped: Technical Issues with intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katarina Kos
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor-investigator, Katarina Kos, Royal Devon and Exeter NHS Foundation Trust
- Investigators
- Katarina Kos, FRCP, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934816
- Sponsor's protocol ID
- 2Myo2013
- Other IDs
- 1308823, 13/SW/0010
- Status last verified
- Feb 2017
- First submitted
- 19 Aug 2013
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of KATP Channel Blockers on GLP-1 and Its Analogues' Mediated Microvascular Function
- ClinicalTrials.gov ID
- NCT01934816
- Acronym / sponsor ID
- 2Myo2013
- Conditions
- Healthy Subjects
- Keywords
- Incretins, KATP channels, intradermal injection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical Issues with intervention
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Katarina KosUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- Jun 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Sep 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.
This study aims to examine the involvement of KATP channels on the microvascular actions of the incretin GLP-1 and its analogues in healthy individuals and to determine whether the acute oral administration of different KATP channel blockers which are oral medications for Type 2 diabetes such as Glibenclamide and Glimepiride differentially modulate the microvascular responses in these individuals.
Detailed description
In addition to the glucose lowering effect, incretin based therapies have also an effect on the vascular system. Previous animal work and initial human studies suggest that incretins may be cardioprotective and act as vasodilators through opening of KATP channels.
Initial evidence suggests that beneficial vascular effects of incretin modifying agents may be nullified by the co-current treatment of the sulfonylurea (SU) drug glibenclamide. The investigators hypothesis is that the GLP-1 and SUs may have conflicting effects on the KATP channels and thus vascular function.
Interestingly the vascular actions of GLP-1 were not modified by a different treatment SUs called glimepiride, thereby raising the possibility that SUs differentially modulating the vascular actions of GLP-1 though this remains controversial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glimepiride | Experimental | Other: Intradermal injections of GLP-1 and its analogues4mg of Glimepiride once only before vascular testing and intradermal injections of GLP-1 and its analogues |
| Placebo tablet | Placebo comparator | Other: Intradermal injections of GLP-1 and its analoguesPlacebo tablet is given in the morning of the intradermal injections of GLP-1 and its analogues |
| Glyburide | Active comparator | Other: Intradermal injections of GLP-1 and its analogues10mg of Glyburide before study visit and intradermal injections of GLP-1 and its analogues |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≤ 25 kg/m2
Key exclusion criteria (13 listed)
- current or past history of diabetes (HbA1C more or equal 45mmol/mol)
- history of postprandial hypoglycaemia and dumping syndrome
- established cardiovascular disease
- established cerebrovascular disease
- blood pressure ≥ 140/85 mmHg
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 |
|---|---|---|
| Intradermal injections of GLP-1 and its analoguesAlso: microinjection of GLP-1 (native GLP-1), and its analogues such as Exenatide(Byetta), and Liraglutide (Victoza)native GLP-1,Exenatide (Byetta)and Liraglutide (Victoza) will be microinjected at the same visit in no particular order in all study arms | Other | Glimepiride, Glyburide, Placebo tablet |
Primary outcome
Change in skin blood flow to GLP-1 and its analogues
Time frame: 6 weeks
Skin blood flow will be assessed before and after microinjection of GLP-1 or its analogues and the injection site monitored and compared to sites injected with placebo
Results and safety
The study was stopped early (reason given: Technical Issues with intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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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.
Katarina Kos, FRCP, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal injections of GLP-1 and its analogues in people with Healthy Subjects, run by Katarina Kos at 1 site in United Kingdom.
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 13 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: stopped early, as of the sponsor's last update on 17 Feb 2017. 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Technical Issues with intervention). Results are not available in the source record.
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?
Change in skin blood flow to GLP-1 and its analogues (time frame: 6 weeks). 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 17 Feb 2017; AzTrials last refreshed its copy on 2 Nov 2026.