Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
63 participants
INTERVENTIONAL
2012-08-31
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GLP-1 and Microvascular Function in Type 2 Diabetes
NCT01740921
Incretin and KATP Channels
NCT01934816
Glucagon-like Peptide 1 (GLP-1) and Endothelial Dysfunction in Metabolic Syndrome
NCT00856700
Blood Pressure Outcomes With Liraglutide Therapy
NCT01755572
Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes
NCT02777073
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DPP-IV inhibitor
Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues
GLP-1
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
Placebo
Placebo pill
One placebo tablet before microinjection
GLP-1
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GLP-1
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Obese BMI ≥30.0kg/m2
* Non diabetic subjects and subjects with Type 2 diabetes on stable medication for at least 3 months
Exclusion Criteria
* Raynaud's disease
* current treatment with any anti-hypertensive
* lipid lowering therapies
* severe hepatic impairment
* pregnancy and lactation
* 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%)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Diabetes UK
OTHER
Katarina Kos
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Katarina Kos
Consultant Physician and Senior Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katarina Kos, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Institue of Biomedical and Clinical Sciences, Peninsula Medical School, University of Exeter
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diabetes and Vascular Center
Exeter, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1204620
Identifier Type: OTHER
Identifier Source: secondary_id
11/SW/0195
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.