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Trial · Interventional

CompletedNot applicableRegistry data

The Microvascular Function of GLP-1 and Its Analogues

NCTNCT01677104 (opens ClinicalTrials.gov in a new tab)Other id11/SW/0195Other id1204620
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
63 participants (estimated)
Sponsor
Katarina Kos · Other
Design
Randomized · Triple masking
Countries
1 country

United Kingdom

Start
Aug 2012
Primary completion
Jul 2014
Completion
Jul 2014
First posted
31 Aug 2012 (estimated)
Last update posted
13 Apr 2017
Conditions
Type 2 Diabetes · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. N/A

    The Microvascular Function of GLP-1 and Its Analogues

    NCT01677104

    Aug 2012 to Jul 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GLP-1Drug
  • PlaceboDrug

Arms2

  • Active comparator

    DPP-IV inhibitor

    Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues

  • Placebo comparator

    Placebo pill

    One placebo tablet before microinjection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. skin blood flow

    Time frame · 3 hours

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

10 results

Locally delivered GLP-1 analogues liraglutide and exenatide enhance microvascular perfusion in individuals with and without type 2 diabetes.

Aung et al. 2019Diabetologiacited by 21

PMID 31203378PMC6677680DOI 10.1007/s00125-019-4918-xPUB-31203378

CC BY10 results
Download PDFSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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%)

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