Type 2 DiabetesGLP-1ADDSNCT01740921
GLP-1 and Microvascular Function in Type 2 Diabetes
A study testing Liraglutide, diet and Aspirin in people with Type 2 Diabetes, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Liraglutide, diet and Aspirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes and an HbA1C between 7-8.5% on a stable dose of sulphonylurea and/or metformin
Who cannot join
- use of insulin
- corticosteroids
- contraceptives, tamoxifen
- methotrexate
- DPP-IV inhibitors
- pregnancy
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Peninsula Clinical Research Facility
Exeter, EX2 5DW
About this study
Official title: Does Glucagon-like Polypeptide 1 Improve Vascular Function and Inflammation?
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Liraglutide, diet, Aspirin
- Keywords
- GLP-1 analogues, microvascular, inflammation, fat tissue, clot structure
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza, GLP-1 analogue
Administered once daily
dietOther
Also called caloric restriction
reduction of caloric intake to promote weight loss
AspirinDrug
300mg of Aspirin per day
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | Liraglutide (Victoza) daily injections Receives: Drug: Liraglutide |
| diet | Placebo comparator | reduction in calorie intake Receives: Other: diet |
| Aspirin | Placebo comparator | Aspirin 300mg once daily Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of baseline skin maximum hyperaemia at 4 months
laser doppler fluximetry
Measured: baseline and 4 months
Secondary outcomes (3)
change of baseline peripheral arterial tone at 4 months
ITAMAR
Measured: baseline and 4 months
change of baseline endothelial-dependent vasodilation at 4 months
iontophoresis
Measured: baseline and 4 months
change of baseline capillary density at 4 months
capillaroscopy
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Principal investigator, Katarina Kos, Royal Devon and Exeter NHS Foundation Trust
- Investigators
- Katarina Kos, MD,PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740921
- Sponsor's protocol ID
- 066
- Other IDs
- 10/H0106/29
- Acronym
- GLP-1ADDS
- Status last verified
- Feb 2017
- First submitted
- 22 Nov 2012
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28049736
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Glucagon-like Polypeptide 1 Improve Vascular Function and Inflammation?
- ClinicalTrials.gov ID
- NCT01740921
- Acronym / sponsor ID
- GLP-1ADDS / 066
- Conditions
- Type 2 Diabetes
- Keywords
- GLP-1 analogues, microvascular, inflammation, fat tissue, clot structure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: LiraglutideLiraglutide (Victoza) daily injections |
| diet | Placebo comparator | Other: dietreduction in calorie intake |
| Aspirin | Placebo comparator | Drug: AspirinAspirin 300mg once daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes and an HbA1C between 7-8.5% on a stable dose of sulphonylurea and/or metformin
Key exclusion criteria (16 listed)
- use of insulin
- corticosteroids
- contraceptives, tamoxifen
- methotrexate
- DPP-IV inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Victoza, GLP-1 analogueAdministered once daily | Drug | Liraglutide |
| dietAlso: caloric restrictionreduction of caloric intake to promote weight loss | Other | diet |
| Aspirin300mg of Aspirin per day | Drug | Aspirin |
Primary outcome
change of baseline skin maximum hyperaemia at 4 months
Time frame: baseline and 4 months
laser doppler fluximetry
3 secondary outcomes
change of baseline peripheral arterial tone at 4 months
Time frame: baseline and 4 months
change of baseline endothelial-dependent vasodilation at 4 months
Time frame: baseline and 4 months
change of baseline capillary density at 4 months
Time frame: baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Background: PubMed 28049736Pastel 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina Kos, MD,PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide, diet and Aspirin in people with Type 2 Diabetes, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of baseline skin maximum hyperaemia at 4 months (time frame: baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.