Use of diazoxide in acute hypoglycaemia

• Research type

  Research Study

• Full title

  Use of diazoxide in hypoglycaemia

• IRAS ID

  89984

• Contact name

  Priya George

• Eudract number

  2011-005011-93

• Research summary

  We know that intensive insulin therapy and tight glucose control is associated with reduction of diabetic complications. However, many patients on insulin don't achieve this because of the risk and the fear of hypoglycaemia (too low blood glucose). There has been a lot of work done recently looking at the mechanisms by which the brain detects hypoglycaemia. A key player is a potassium channel in the brain (KATP channel). Studies have shown that when these channels are opened, there is a release of hormones such as adrenaline that can help in raising blood sugars to counteract and increase awareness of hypoglycaemia. Our study aims to look at an old drug called diazoxide, which is able to open KATP channels. We aim to see if diazoxide will amplify the release of hormones such as adrenaline when the blood sugar is low. If this is the case, this will aid quicker recovery following hypoglycaemia. We aim to do this by performing a well established experimental protocol that has been performed safely over the last 20 years called a clamp study. The clamp study will involve slowly bringing the blood sugars down using insulin and intravenous glucose in a controlled fashion. The main outcome will be the hormonal responses (adrenaline response) at a blood sugar level of 2.5mmol/L. Symptoms of hypoglycaemia will be monitored, as well as working memory tests using standardised questionnaires. The design of our study will be a randomised trial comparing the effects of diazoxide with placebo in which all patients will receive both diazoxide and placebo in random order (crossover design).

• REC name

  Scotland A REC

• REC reference

  11/SS/0082

• Date of REC Opinion

  2 Dec 2011

• REC opinion

  Further Information Favourable Opinion