Vitamin D replacement in Insulin resistant South Asians

• Research type

  Research Study

• Full title

  Can Vitamin D Replacement Reduce Insulin resistance In South Asians with Vitamin D Deficiency?

• IRAS ID

  63824

• Sponsor organisation

  The University of Leicester

• Eudract number

  2010-024213-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The process of developing diabetes can result from either natural insulin levels not functioning effectively (known as insulin resistance) and/or the body not secreting enough insulin. Vitamin D is involved with body defences and may increase insulin function in people with insulin resistance; this could eventually reduce blood glucose levels and the risk of developing diabetes. People with low Vitamin D levels are more likely to develop diabetes. Therefore, if people with low vitamin D levels take Vitamin D replacement, this may protect from developing future diabetes. Compared with their white European counterparts, Leicester south Asians have less than half the circulating vitamin D and are twice as likely to develop diabetes. Standard UK recommended doses of Vitamin D are not sufficient to increase insulin action or reduce glucose levels, nor unlikely to replace very low levels of Vitamin D effectively. Higher doses of Vitamin D are known to be safe in people with very low Vitamin D levels and therefore now require testing for their role in decreasing diabetes risk. We aim to test whether replacing Vitamin D levels with high dose Vitamin D reduces insulin resistance compared to using standard dose Vitamin D in south Asians at increased risk of diabetes. 100 participants will be randomly assigned to high or standard dose Vitamin D in a 6 month study. Safety checks will ensure participants who could be at harm will be excluded before the trial begins. In summary, this important study will aim to create a simple, inexpensive method of decreasing diabetes risk; this is important as the prevalence of both diabetes and Vitamin D deficiency are set to rise.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/H0406/6

• Date of REC Opinion

  7 Mar 2011

• REC opinion

  Further Information Favourable Opinion