Incretin and KATP Channels

Healthy Subjects Clinical Trial

Official title:

Effects of KATP Channel Blockers on GLP-1 and Its Analogues' Mediated Microvascular Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01934816
• Other study ID #: 2Myo2013
• Secondary ID: 130882313/SW/001
• Status: Terminated
• Phase: N/A
• First received: August 19, 2013
• Last updated: February 16, 2017
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2017
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Glimepiride differentially modulate the microvascular responses in these individuals.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter

Sponsors (2)

Lead Sponsor	Collaborator
Katarina Kos	University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks