The Microvascular Function of GLP-1 and Its Analogues

April 12, 2017 updated by: Katarina Kos

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Exeter, United Kingdom, EX2 5AX
        • Diabetes and Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DPP-IV inhibitor
Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues
Drug: Placebo
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)
Placebo Comparator: Placebo pill
One placebo tablet before microinjection
Drug: Placebo
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin blood flow
Time Frame: 3 hours
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
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katarina Kos

Collaborators

Diabetes UK

Investigators

  • Principal Investigator: Katarina Kos, MD, PHD, Institue of Biomedical and Clinical Sciences, Peninsula Medical School, University of Exeter

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

August 31, 2012

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/SW/0195
  • 1204620 (Other Identifier: Research and Development)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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