Do the gut hormones modify vascular function in obesity?

• Research type

  Research Study

• Full title

  Does modulating the gut hormones, incretins, modify vascular function, thereby reducing the risk of vascular complications in insulin resistant individuals?

• IRAS ID

  14506

• Sponsor organisation

  University of Exeter

• Eudract number

  2009-013100-32

• ISRCTN Number

  Unknown

• Research summary

  Diabetes is associated with changes in blood vessel function that may eventually lead to blindness (macular oedema / thickening), kidney failure, loss of limbs (amputation) and an increased risk of heart disease. These alterations in blood vessel function may also be present in individuals at an increased risk of diabetes, for example individuals that are overweight. The aim of this study is to examine whether increasing levels of the gut hormones (incretins) improves blood vessel function, and therefore also improves kidney function and have beneficial effects at the back of the eye (macular). Incretin levels will be increased by preventing their breakdown with the administration of Vildagliptin, a glucose lowering therapy commonly used in diabetes. The study will recruit 15 obese individuals, and will last for 7-8 months for each participant. Following study entry each participant will undergo a series of non-painful tests to examine blood vessel function over 3-5 mornings, over 2-3 weeks. Following these initial assessments subjects will be randomly allocated to either placebo (dummy) or Vildagliptin tablets for 12 weeks, followed by a 4 week break, after which the subject will then receive the second set of tablets (either placebo or Vildagliptin). Blood vessel function assessments will be repeated at the end of each set of tablets. This study will provide information on whether increasing incretin levels with Vildagliptin, improves blood vessel function in obese individuals, and whether these are improvements are associated with favorable improvements in kidney function and in the eye. As a result this study will further our understanding of the blood vessels function in individuals at risk of diabetes and may provide vital information on potential strategies on preventing diabetic related health complications.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/33

• Date of REC Opinion

  23 Jul 2009

• REC opinion

  Further Information Favourable Opinion