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Trial · Interventional

CompletedNot applicableRegistry data

GLP-1 and Microvascular Function in Type 2 Diabetes

Short name GLP-1ADDS

NCTNCT01740921 (opens ClinicalTrials.gov in a new tab)Other id066Other id10/H0106/29
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
39 participants (actual)
Sponsor
Royal Devon and Exeter NHS Foundation Trust · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Jan 2011
Primary completion
Dec 2015
Completion
Feb 2016
First posted
4 Dec 2012 (estimated)
Last update posted
17 Feb 2017
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014201520162017
  1. N/A

    GLP-1ADDS

    NCT01740921

    Jan 2011 to Feb 2016

Registry summary

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

Some gut hormones, called incretins, stimulate insulin production in order to control sugar levels but also activate brain centres and signal to stop eating. Current administration of incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the skin) injection and has been routinely available for diabetic patients for more than 4 years. It is an effective treatment for the lowering of blood glucose with an average weight loss of about 3-4kg.Recent evidence, from animal studies and limited human studies, suggests that incretins based treatments may also have beneficial effects on blood vessel function. However, it is not known whether this effect is by direct action on the blood vessel independent of an improvement of latent inflammation which is typically associated with weight loss or an anti-inflammatory effect of the incretin treatment itself. The aim of this study is to determine whether the incretin-based diabetes treatment with the GLP-1 (Glucagon-like peptide 1) analogue Liraglutide (also known as Victoza), which mimics the actions of incretins, improves blood vessel function in individuals with type 2 diabetes. It will determine whether the improvement in blood vessel function is independent of the effect of weight loss and changes in inflammation. This by the study of vascular function before and after 4 months of Victoza treatment in subjects with Type 2 diabetes in comparison with 1) participants randomized to hypo-caloric diet to achieve a similar weight loss than with Victoza and 2) participants randomized to treatment with once daily aspirin. Comprehensive assessment of blood vessel function, body fat distribution and metabolic profile at baseline and at the end of the treatment phase will be combined with assessments of inflammation markers in blood and in fat tissue biopsies.

Interventions

  • LiraglutideDrug
  • dietOther
  • AspirinDrug

Arms3

  • Active comparator

    Liraglutide

    Liraglutide (Victoza) daily injections

  • Placebo comparator

    diet

    reduction in calorie intake

  • Placebo comparator

    Aspirin

    Aspirin 300mg once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. change of baseline skin maximum hyperaemia at 4 months

    Time frame · baseline and 4 months

    Registry description

    laser doppler fluximetry

Secondary outcomes(3)

  1. change of baseline peripheral arterial tone at 4 months

    Time frame · baseline and 4 months

    Registry description

    ITAMAR

  2. change of baseline endothelial-dependent vasodilation at 4 months

    Time frame · baseline and 4 months

    Registry description

    iontophoresis

  3. change of baseline capillary density at 4 months

    Time frame · baseline and 4 months

    Registry description

    capillaroscopy

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 · 2017

8 results

GLP-1 analogue-induced weight loss does not improve obesity-induced AT dysfunction.

Pastel et al. 2017Clinical science (London, England : 1979)cited by 42

PMID 28049736DOI 10.1042/cs20160803PUB-28049736

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes and an HbA1C between 7-8.5% on a stable dose of sulphonylurea and/or metformin Exclusion Criteria: * use of insulin * corticosteroids * contraceptives, tamoxifen * methotrexate * DPP-IV inhibitors * pregnancy * lactation * endocrine disorders * acute MI or cerebrovascular disease * Raynaud's disease or connective tissue disease * current or previous history of malignancy * subjects treated with ergotamine derivatives * unstable blood pressure for the last 3 months * current treatment with warfarin * subjects on any anti-inflammatory or anti-platelet agents * history of any bleeding disorders and GI bleeds.

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