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NCT Number: NCT01677104

The Microvascular Function of GLP-1 and Its Analogues

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes and Vascular Center

Exeter, EX2 5AX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

GLP-1

Drug

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

Other names: native GLP-1(7,36), Exenatide (Byetta), Liraglutide (Vicotza)

Placebo

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Katarina Kos

Other

Collaborators

  • Diabetes UK

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 31, 2012
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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