The Microvascular Function of GLP-1 and Its Analogues

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 18, 2014
Last verified: February 2014

August 29, 2012
February 18, 2014
August 2012
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01677104 on ClinicalTrials.gov Archive Site
Not Provided
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The Microvascular Function of GLP-1 and Its Analogues
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.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Type 2 Diabetes
  • Obesity
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
63
October 2014
July 2014   (final data collection date for primary outcome measure)

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%)
Both
18 Years and older
Yes
Contact: Katarina Kos, MD, PHD 01392406761 katarina.kos@pcmd.ac.uk
Contact: Kim Gooding, PhD 01392403081 kim.gooding@pcmd.ac.uk
United Kingdom
 
NCT01677104
11/SW/0195, 1204620
Yes
Katarina Kos, Royal Devon and Exeter NHS Foundation trust
Katarina Kos
Diabetes UK
Principal Investigator: Katarina Kos, MD, PHD Institue of Biomedical and Clinical Sciences, Peninsula Medical School, University of Exeter
Royal Devon and Exeter NHS Foundation Trust
February 2014

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