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The Vascular Effects of Vildagliptin in Insulin Resistant Individuals

This study has been completed.
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals
Information provided by (Responsible Party):
David Strain, Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01122641
First received: May 12, 2010
Last updated: April 24, 2017
Last verified: April 2017
  Purpose

Animal models have demonstrated that incretins have a glucose-independent effect on vascular perfusion, and there is limited evidence that incretins may enhance endothelial function in healthy subjects. Currently DPP-4 inhibition increases levels of the endogenous incretin Glucagon-like Peptide 1 (GLP-1) and is licensed for the treatment of hyperglycaemia in type 2 diabetes. They are positioned as third or even fourth line therapy after metformin, sulphonylureas ± glitazones, however recent analyses of cardiovascular outcomes in glitazones and sulphonylureas suggest at best they do not reduce cardiovascular endpoints, and may increase some outcomes. If the vascular benefits suggested in animal models are realised in humans this should see the DPP-4 inhibitors moved to second line and possibly 1st line.

In order to realise the potential the investigators would like initially to demonstrate increases in vascular perfusion and function in a placebo controlled trial using accurate surrogates for vascular function in patients with insulin resistance and obesity.

The investigators hypothesis is that by increasing incretin activity in insulin resistant states the investigators will lower capillary pressure and improve microvascular function, which will be accompanied by a reduction in macular thickness (by reducing macular oedema) and microalbuminuria, recognised surrogates for early diabetic retinopathy and renal failure respectively.


Condition Intervention Phase
Insulin Resistance
Microvascular Disease
Drug: Vildagliptin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Does Modulating the Gut Hormones, Incretins, Modify Vascular Function, Thereby Reducing the Risk of Vascular Complications in Insulin Resistant Individuals?

Further study details as provided by Royal Devon and Exeter NHS Foundation Trust:

Primary Outcome Measures:
  • Capillary pressure [ Time Frame: 3 months ]
    Capillary pressure will be reduced in those treated with DPP-4 inhibitor


Secondary Outcome Measures:
  • Macular thickness [ Time Frame: 3 months ]
    Measured by optical coherence tomography


Enrollment: 15
Study Start Date: May 2010
Study Completion Date: August 1, 2014
Primary Completion Date: August 1, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Matched tablets
Experimental: Vildagliptin
Vildagliptin 50mg bid
Drug: Vildagliptin
Vildagliptin 50mg bid
Other Name: Galvus

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese (BMI >30)
  • High FinRisk score

Exclusion Criteria:

  • Diabetes
  • Overt cardiovascular disease
  • Raynauds disease
  • Current treatment with any anti-hypertensive, oral hypoglycaemic or lipid lowering therapies
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01122641

Locations
United Kingdom
Diabetes and Vascular Research Department
Exeter, Devon, United Kingdom, EX2 5AX
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: David Strain, PI, Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01122641     History of Changes
Other Study ID Numbers: 2009-013100-32
09/H0206/33 ( Other Identifier: REC study number )
Study First Received: May 12, 2010
Last Updated: April 24, 2017

Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Insulin resistance
incretins
DPP4 inhibitors
vildagliptin
microcirculation

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vildagliptin
Insulin
Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 25, 2017