Incretin and KATP Channels

NCT01934816 | Terminated DMC

• 3 other identifiers: 2Myo2013130882313/SW/0010
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

Incretins, KATP channels, intradermal injection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Glimepiride

EXPERIMENTAL

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

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

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

Other: Intradermal injections of GLP-1 and its analogues

Interventions

Intradermal injections of GLP-1 and its analogues OTHER

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

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

Glimepiride; Glyburide; Placebo tablet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≤ 25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Katarina Kos: lead
• University of Exeter: collaborator

Study Sites (1)

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX25DW, United Kingdom

Location

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Katarina Kos, FRCP, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: September 4, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

GB (1)