Type 2 DiabetesNCT01677104
The Microvascular Function of GLP-1 and Its Analogues
A study testing GLP-1 in people with Type 2 Diabetes and Obesity, run by Katarina Kos at 1 site in United Kingdom.
Trial summary
Incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- GLP-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Jul 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lean BMI ≤ 25.0 kg/m2
- Obese BMI ≥30.0kg/m2
- Non diabetic subjects and subjects with Type 2 diabetes on stable medication for at least 3 months
Who cannot join
- cardiovascular disease
- Raynaud's disease
- current treatment with any anti-hypertensive
- lipid lowering therapies
- severe hepatic impairment
- pregnancy and lactation
Show all 13Show fewer
- subjects with Type 2 diabetes on insulin therapy
- subjects with Type 2 diabetes on sulphonylureas
- subjects with Type 2 diabetes on incretin based therapies
- subjects with Type 2 diabetes and peripheral vascular disease
- subjects with Type 2 diabetes and history of advanced retinopathy
- subjects with Type 2 diabetes and advanced nephropathy
- subjects with Type 2 diabetes with uncontrolled diabetes (HbA1c > 8.5%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Microvascular Function of GLP-1 and Its Analogues in Humans, in Vivo: the Role of DPP-IV Inhibition
Incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in animals. Particularly little is known about clinically relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with type 2 diabetes.
The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced by the body.
The study aims to examine the response of GLP-1 and its analogues on small blood vessels and examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese individuals and subjects with Type 2 diabetes.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- GLP-1, Placebo
- Keywords
- GLP-1, DPP-IV inhibitor, microcirculation, Exenatide, Liraglutide, Linagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
Also called native GLP-1(7,36), Exenatide (Byetta), Liraglutide (Vicotza)
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DPP-IV inhibitor | Active comparator | Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues Receives: Drug: GLP-1; Drug: Placebo |
| Placebo pill | Placebo comparator | One placebo tablet before microinjection Receives: Drug: GLP-1; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin blood flow
skin blood flow will be assessed before and after microinjection of GLP-1 or its analogues and the injection site monitored and compared to sites injected with placebo
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionJul 2014
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katarina Kos
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Responsible party
- Sponsor-investigator, Katarina Kos, Royal Devon and Exeter NHS Foundation Trust
- Investigators
- Katarina Kos, MD, PHD, Principal investigator, Institue of Biomedical and Clinical Sciences, Peninsula Medical School, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677104
- Sponsor's protocol ID
- 11/SW/0195
- Other IDs
- 1204620
- Status last verified
- Apr 2017
- First submitted
- 29 Aug 2012
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aung MM, Slade K, Freeman LAR, Kos K, Whatmore JL, Shore AC, Gooding KM. Locally delivered GLP-1 analogues liraglutide and exenatide enhance microvascular perfusion in individuals with and without type 2 diabetes. Diabetologia. 2019 Sep;62(9):1701-1711. doi: 10.1007/s00125-019-4918-x. Epub 2019 Jun 16.
PubMed 31203378
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microvascular Function of GLP-1 and Its Analogues in Humans, in Vivo: the Role of DPP-IV Inhibition
- ClinicalTrials.gov ID
- NCT01677104
- Acronym / sponsor ID
- 11/SW/0195
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- GLP-1, DPP-IV inhibitor, microcirculation, Exenatide, Liraglutide, Linagliptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Katarina KosUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Aug 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.
Incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in animals. Particularly little is known about clinically relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with type 2 diabetes.
The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced by the body.
The study aims to examine the response of GLP-1 and its analogues on small blood vessels and examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese individuals and subjects with Type 2 diabetes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP-IV inhibitor | Active comparator | Drug: GLP-1, Drug: PlaceboLinagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues |
| Placebo pill | Placebo comparator | Drug: GLP-1, Drug: PlaceboOne placebo tablet before microinjection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lean BMI ≤ 25.0 kg/m2
- Obese BMI ≥30.0kg/m2
- Non diabetic subjects and subjects with Type 2 diabetes on stable medication for at least 3 months
Key exclusion criteria (13 listed)
- cardiovascular disease
- Raynaud's disease
- current treatment with any anti-hypertensive
- lipid lowering therapies
- severe hepatic impairment
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 |
|---|---|---|
| GLP-1Also: native GLP-1(7,36), Exenatide (Byetta), Liraglutide (Vicotza)GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition | Drug | DPP-IV inhibitor, Placebo pill |
| Placebo | Drug | DPP-IV inhibitor, Placebo pill |
Primary outcome
skin blood flow
Time frame: 3 hours
skin blood flow will be assessed before and after microinjection of GLP-1 or its analogues and the injection site monitored and compared to sites injected with placebo
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 13 Apr 2017.
- Derived from this study: PubMed 31203378Aung MM, Slade K, Freeman LAR, Kos K, Whatmore JL, Shore AC, Gooding KM. Locally delivered GLP-1 analogues liraglutide and exenatide enhance microvascular perfusion in individuals with and without type 2 diabetes. Diabetologia. 2019 Sep;62(9):1701-1711. doi: 10.1007/s00125-019-4918-x. Epub 2019 Jun 16.
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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
Institue of Biomedical and Clinical Sciences, Peninsula Medical School, 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 GLP-1 in people with Type 2 Diabetes and Obesity, run by Katarina Kos 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 3 inclusion and 13 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 13 Apr 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?
skin blood flow (time frame: 3 hours). 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 NCT01677104, 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 13 Apr 2017.