The Microvascular Function of GLP-1 and Its Analogues

Obesity Clinical Trial

Official title:

The Microvascular Function of GLP-1 and Its Analogues in Humans, in Vivo: the Role of DPP-IV Inhibition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677104
• Other study ID #: 11/SW/0195
• Secondary ID: 1204620
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: April 12, 2017
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2017
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Drug:
• GLP-1
GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
• Placebo

Locations

Country	Name	City	State
United Kingdom	Diabetes and Vascular Center	Exeter

Sponsors (2)

Lead Sponsor	Collaborator
Katarina Kos	Diabetes UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 hours