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| ID | Type | Description | Link |
|---|---|---|---|
| 10/H0106/29 | Other Identifier | Research Ethics Committee |
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| Name | Class |
|---|---|
| University of Exeter | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Active Comparator | Liraglutide (Victoza) daily injections |
|
| diet | Placebo Comparator | reduction in calorie intake |
|
| Aspirin | Placebo Comparator | Aspirin 300mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Administered once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change of baseline skin maximum hyperaemia at 4 months | laser doppler fluximetry | baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| change of baseline peripheral arterial tone at 4 months | ITAMAR | baseline and 4 months |
| change of baseline endothelial-dependent vasodilation at 4 months | iontophoresis |
| Measure | Description | Time Frame |
|---|---|---|
| change of baseline clot structure at 4 months | rigidity and elasticity of clot structure | baseline and 4 months |
| change of baseline adipose tissue inflammation at 4 months | adipose tissue biopsies will be analysed for gene expression and protein content of inflammatory cytokines |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarina Kos, MD,PhD | University of Exeter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula Clinical Research Facility | Exeter | EX2 5DW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28049736 | Background | Pastel E, McCulloch LJ, Ward R, Joshi S, Gooding KM, Shore AC, Kos K. GLP-1 analogue-induced weight loss does not improve obesity-induced AT dysfunction. Clin Sci (Lond). 2017 Mar 1;131(5):343-353. doi: 10.1042/CS20160803. Epub 2017 Jan 3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D004032 | Diet |
| D031204 | Caloric Restriction |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| diet | Other | reduction of caloric intake to promote weight loss |
|
|
| Aspirin | Drug | 300mg of Aspirin per day |
|
| baseline and 4 months |
| change of baseline capillary density at 4 months | capillaroscopy | baseline and 4 months |
| baseline and 4 months |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |