The Microvascular Function of GLP-1 and Its Analogues
This study is currently recruiting participants.
Verified August 2012 by Royal Devon and Exeter NHS Foundation Trust
Sponsor:
Katarina Kos
Collaborator:
Diabetes UK
Information provided by (Responsible Party):
Katarina Kos, Royal Devon and Exeter NHS Foundation trust
ClinicalTrials.gov Identifier:
NCT01677104
First received: August 29, 2012
Last updated: August 31, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Obesity |
Drug: GLP-1 Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | The Microvascular Function of GLP-1 and Its Analogues in Humans, in Vivo: the Role of DPP-IV Inhibition |
Resource links provided by NLM:
Further study details as provided by Royal Devon and Exeter NHS Foundation Trust:
Primary Outcome Measures:
- skin blood flow [ Time Frame: 3 hours ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 63 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: DPP-IV inhibitor
Linagliptin 5mg (Tradjenta) before microinjection of GLP-1 and its analogues
|
Drug: GLP-1
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
Other Names:
Drug: Placebo
Other Name: placebo
|
|
Placebo Comparator: Placebo pill
One placebo tablet before microinjection
|
Drug: GLP-1
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
Other Names:
Drug: Placebo
Other Name: placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- cardiovascular disease
- 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%)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677104
Contacts
| Contact: Katarina Kos, MD, PHD | 01392406761 | katarina.kos@pcmd.ac.uk |
| Contact: Kim Gooding, PhD | 01392403081 | kim.gooding@pcmd.ac.uk |
Locations
| United Kingdom | |
| Diabetes and Vascular Center | Recruiting |
| Exeter, United Kingdom, EX2 5AX | |
| Contact: Kim Gooding, PhD 01392403081 kim.gooding@pcmd.ac.uk | |
| Sub-Investigator: Kim Gooding, PhD | |
| Principal Investigator: Angela Shore, PhD | |
Sponsors and Collaborators
Katarina Kos
Diabetes UK
Investigators
| Principal Investigator: | Katarina Kos, MD, PHD | Institue of Biomedical and Clinical Sciences, Peninsula Medical School, University of Exeter |
More Information
No publications provided
| Responsible Party: | Katarina Kos, Consultant Physician and Senior Lecturer, Royal Devon and Exeter NHS Foundation trust |
| ClinicalTrials.gov Identifier: | NCT01677104 History of Changes |
| Other Study ID Numbers: | 11/SW/0195, 1204620 |
| Study First Received: | August 29, 2012 |
| Last Updated: | August 31, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
|
GLP-1 DPP-IV inhibitor microcirculation |
Exenatide Liraglutide Linagliptin |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Obesity Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Glucagon-Like Peptide 1 Exenatide Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 16, 2013