Incretin and KATP Channels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Glimepiride

4mg of Glimepiride once only before vascular testing and intradermal injections of GLP-1 and its analogues

Group Type EXPERIMENTAL

Intradermal injections of GLP-1 and its analogues

Intervention Type OTHER

native GLP-1,Exenatide (Byetta)and Liraglutide (Victoza) will be microinjected at the same visit in no particular order in all study arms

Placebo tablet

Placebo tablet is given in the morning of the intradermal injections of GLP-1 and its analogues

Group Type PLACEBO_COMPARATOR

Intradermal injections of GLP-1 and its analogues

Intervention Type OTHER

native GLP-1,Exenatide (Byetta)and Liraglutide (Victoza) will be microinjected at the same visit in no particular order in all study arms

Glyburide

10mg of Glyburide before study visit and intradermal injections of GLP-1 and its analogues

Group Type ACTIVE_COMPARATOR

Intradermal injections of GLP-1 and its analogues

Intervention Type OTHER

native GLP-1,Exenatide (Byetta)and Liraglutide (Victoza) will be microinjected at the same visit in no particular order in all study arms

Interventions

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Intradermal injections of GLP-1 and its analogues

native GLP-1,Exenatide (Byetta)and Liraglutide (Victoza) will be microinjected at the same visit in no particular order in all study arms

Intervention Type OTHER

Other Intervention Names

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microinjection of GLP-1 (native GLP-1) and its analogues such as Exenatide(Byetta) and Liraglutide (Victoza)

Eligibility Criteria

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Inclusion Criteria

* BMI ≤ 25 kg/m2

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes