The Vascular Effects of Vildagliptin in Insulin Resistant Individuals
Does Modulating the Gut Hormones, Incretins, Modify Vascular Function, Thereby Reducing the Risk of Vascular Complications in Insulin Resistant Individuals?
2 other identifiers
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 12, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedApril 25, 2017
April 1, 2017
4.3 years
May 12, 2010
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Capillary pressure
Capillary pressure will be reduced in those treated with DPP-4 inhibitor
3 months
Secondary Outcomes (1)
Macular thickness
3 months
Study Arms (2)
Placebo
PLACEBO COMPARATORVildagliptin
EXPERIMENTALVildagliptin 50mg bid
Interventions
Eligibility Criteria
You may qualify if:
- Obese (BMI \>30)
- High FinRisk score
You may not qualify if:
- Diabetes
- Overt cardiovascular disease
- Raynauds disease
- Current treatment with any anti-hypertensive, oral hypoglycaemic or lipid lowering therapies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes and Vascular Research Department
Exeter, Devon, EX2 5AX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
May 12, 2010
First Posted
May 13, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
April 25, 2017
Record last verified: 2017-04