Sitaxentan & the systemic & coronary microcirculation in DM

• Research type

  Research Study

• Full title

  A study of the effects of Endothelin-A receptor blockade with Sitaxentan on micro- and macrovascular endothelial function, metabolic control and myocardial function in patients with type 2 diabetes and coronary artery disease.

• IRAS ID

  32095

• Contact name

  David Strain

• Eudract number

  2009-016739-37

• ISRCTN Number

  Unknown

• Research summary

  Diabetes is a common disease and the numbers of people affected is likely to increase. Patients with diabetes have an increased risk of strokes, heart attacks and kidney failure. Most of these disease stem from a dysfunction of the very small blood vessels and the cells lining them. One of the mechanisms for this dysfunction is thought to be due to too much of a hormone called endothelin-1. Tests on diabetic patients show they have more of this hormone in their bodies than people without diabetes. We aim to block the effect of this hormone using a drug that is already available for another condition (Sitaxentan) and examine the effects on the small blood vessels. This work may mean this drug is used in the future to prevent the complications of diabetes. We aim to recruit 30 patients with diabetes and coronary disease. To evaluate the coronary arteries participants who have not had a recent angiogram will be offered a computed tomography coronary angiogram (CAT scan) to rule out significant coronary narrowings. Following entry into the study each participant will have a 4 week course of either Sitaxentan or placebo and then under-go a series of non-painful test to examine the small blood vessel function in their skin and heart and the function of the large blood vessels in the neck and body. These test will be carried out over 2-3 mornings. After the investigations there will be a four week washout period followed by a course of the other medication for 4 weeks (Sitaxentan or placebo) this will be followed by a second round of investigations.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/62

• Date of REC Opinion

  24 Feb 2010

• REC opinion

  Further Information Favourable Opinion