GLP-1 and Microvascular Function in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Liraglutide

Liraglutide (Victoza) daily injections

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

Administered once daily

diet

reduction in calorie intake

Group Type PLACEBO_COMPARATOR

diet

Intervention Type OTHER

reduction of caloric intake to promote weight loss

Aspirin

Aspirin 300mg once daily

Group Type PLACEBO_COMPARATOR

Aspirin

Intervention Type DRUG

300mg of Aspirin per day

Interventions

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Liraglutide

Administered once daily

Intervention Type DRUG

diet

reduction of caloric intake to promote weight loss

Intervention Type OTHER

Aspirin

300mg of Aspirin per day

Intervention Type DRUG

Other Intervention Names

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Victoza GLP-1 analogue caloric restriction

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No