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GLP-1 and Microvascular Function in Type 2 Diabetes (GLP-1ADDS)

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ClinicalTrials.gov Identifier: NCT01740921
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
University of Exeter
Information provided by (Responsible Party):
Katarina Kos, Royal Devon and Exeter NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Liraglutide Other: diet Drug: Aspirin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Glucagon-like Polypeptide 1 Improve Vascular Function and Inflammation?
Study Start Date : January 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Liraglutide
Liraglutide (Victoza) daily injections
Drug: Liraglutide
Administered once daily
Other Names:
  • Victoza
  • GLP-1 analogue

Placebo Comparator: diet
reduction in calorie intake
Other: diet
reduction of caloric intake to promote weight loss
Other Name: caloric restriction

Placebo Comparator: Aspirin
Aspirin 300mg once daily
Drug: Aspirin
300mg of Aspirin per day




Primary Outcome Measures :
  1. change of baseline skin maximum hyperaemia at 4 months [ Time Frame: baseline and 4 months ]
    laser doppler fluximetry


Secondary Outcome Measures :
  1. change of baseline peripheral arterial tone at 4 months [ Time Frame: baseline and 4 months ]
    ITAMAR

  2. change of baseline endothelial-dependent vasodilation at 4 months [ Time Frame: baseline and 4 months ]
    iontophoresis

  3. change of baseline capillary density at 4 months [ Time Frame: baseline and 4 months ]
    capillaroscopy


Other Outcome Measures:
  1. change of baseline clot structure at 4 months [ Time Frame: baseline and 4 months ]
    rigidity and elasticity of clot structure

  2. change of baseline adipose tissue inflammation at 4 months [ Time Frame: baseline and 4 months ]
    adipose tissue biopsies will be analysed for gene expression and protein content of inflammatory cytokines



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740921


Locations
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United Kingdom
Peninsula Clinical Research Facility
Exeter, United Kingdom, EX2 5DW
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
University of Exeter
Investigators
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Principal Investigator: Katarina Kos, MD,PhD University of Exeter

Publications:
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Responsible Party: Katarina Kos, Senior Lecturer and Honorary Consultant Physician, Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01740921     History of Changes
Other Study ID Numbers: 066
10/H0106/29 ( Other Identifier: Research Ethics Committee )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Katarina Kos, Royal Devon and Exeter NHS Foundation Trust:
GLP-1 analogues
microvascular
inflammation
fat tissue
clot structure

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Liraglutide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Hypoglycemic Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists