The Vascular Effects of Vildagliptin in Insulin Resistant Individuals

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Royal Devon and Exeter NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals
Information provided by:
Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01122641
First received: May 12, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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: Double Blind (Subject, 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?

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Capillary pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Capillary pressure will be reduced in those treated with DPP-4 inhibitor


Secondary Outcome Measures:
  • Macular thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured by optical coherence tomography


Estimated Enrollment: 15
Study Start Date: May 2010
Estimated Primary Completion Date: August 2011 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122641

Contacts
Contact: David Strain, MD MRCP 01392 403058 david.strain@pms.ac.uk

Locations
United Kingdom
Diabetes and Vascular Research Department Recruiting
Exeter, Devon, United Kingdom, EX2 5AX
Contact: David Strain    01392 403058    david.strain@pms.ac.uk   
Principal Investigator: Kim Gooding, PhD         
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Dr David Strain, Institute of Biomedical and Clinical Science, Peninsula Medical School
ClinicalTrials.gov Identifier: NCT01122641     History of Changes
Other Study ID Numbers: 2009-013100-32, 09/H0206/33
Study First Received: May 12, 2010
Last Updated: May 12, 2010
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

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
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 15, 2014