The Microvascular Function of GLP-1 and Its Analogues

This study is currently recruiting participants.

Verified August 2012 by Royal Devon and Exeter NHS Foundation Trust

Sponsor:

Collaborator:

Diabetes UK

Information provided by (Responsible Party):

Katarina Kos, Royal Devon and Exeter NHS Foundation trust

ClinicalTrials.gov Identifier:

NCT01677104

First received: August 29, 2012

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2012

Last Updated Date

August 31, 2012

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

skin blood flow [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01677104 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Microvascular Function of GLP-1 and Its Analogues

Official Title ^ICMJE

The Microvascular Function of GLP-1 and Its Analogues in Humans, in Vivo: the Role of DPP-IV Inhibition

Brief Summary

Incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in animals. Particularly little is known about clinically relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with type 2 diabetes.

The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced by the body.

The study aims to examine the response of GLP-1 and its analogues on small blood vessels and examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese individuals and subjects with Type 2 diabetes.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic

Condition ^ICMJE

Type 2 Diabetes
Obesity

Intervention ^ICMJE

Drug: GLP-1
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
Other Names:
- native GLP-1(7,36)
- Exenatide (Byetta)
- Liraglutide (Vicotza)
Drug: Placebo
Other Name: placebo

Study Arm (s)

Active Comparator: DPP-IV inhibitor
Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues
Interventions:
- Drug: GLP-1
- Drug: Placebo
Placebo Comparator: Placebo pill
One placebo tablet before microinjection
Interventions:
- Drug: GLP-1
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Lean BMI ≤ 25.0 kg/m2
Obese BMI ≥30.0kg/m2
Non diabetic subjects and subjects with Type 2 diabetes on stable medication for at least 3 months

Exclusion Criteria:

cardiovascular disease
Raynaud's disease
current treatment with any anti-hypertensive
lipid lowering therapies
severe hepatic impairment
pregnancy and lactation
subjects with Type 2 diabetes on insulin therapy
subjects with Type 2 diabetes on sulphonylureas
subjects with Type 2 diabetes on incretin based therapies
subjects with Type 2 diabetes and peripheral vascular disease
subjects with Type 2 diabetes and history of advanced retinopathy
subjects with Type 2 diabetes and advanced nephropathy
subjects with Type 2 diabetes with uncontrolled diabetes (HbA1c > 8.5%)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Katarina Kos, MD, PHD	01392406761	katarina.kos@pcmd.ac.uk
Contact: Kim Gooding, PhD	01392403081	kim.gooding@pcmd.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01677104

Other Study ID Numbers ^ICMJE

11/SW/0195, 1204620

Has Data Monitoring Committee

Yes

Responsible Party

Katarina Kos, Royal Devon and Exeter NHS Foundation trust

Study Sponsor ^ICMJE

Katarina Kos

Collaborators ^ICMJE

Diabetes UK

Investigators ^ICMJE

Principal Investigator:

Katarina Kos, MD, PHD

Institue of Biomedical and Clinical Sciences, Peninsula Medical School, University of Exeter

Information Provided By

Royal Devon and Exeter NHS Foundation Trust

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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