Vitamin D supplementation in impaired fasting glycaemia, version 2.0
Research type
Research Study
Full title
The effect of oral Vitamin D supplementation on endothelial function, vascular inflammation, oxidative stress and insulin sensitivity in patients with impaired fasting glucose: A randomised, double blinded, placebo controlled trial
IRAS ID
161954
Contact name
Jana Bujanova
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Eudract number
2014-002766-73
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Impaired fasting glucose (IFG) is associated with increased risk of progression to Type 2 Diabetes and problems with circulation which represent a significant health economic burden. This makes this population an ideal target for preventive interventions. Prevalence of IFG is rising globally and with it an increased risk of cardiovascular disease (angina, heart attack, stroke) and mortality. Studies showed that this risk is most likely linked to damage of the lining of blood vessels (endothelium) which leads to their narrowing. The mechanisms that lead to endothelium damage seem to be raised blood sugar, reduced body’s responsiveness to its own insulin (insulin resistance) and increased inflammation and production of harmful chemicals (oxidative stress). These mechanisms are also present in vitamin D deficiency and seem to improve with vitamin D supplementation. We therefore hypothesise that Vitamin D supplementation in this population irrespective of their vitamin D levels can improve endothelial function, insulin sensitivity and markers of cardiovascular risk. Early intervention with vitamin D supplementation might provide an inexpensive public health opportunity to delay/reverse progression from IFG to diabetes and delay or reverse the cascade of events leading to blood vessels narrowing that eventually leads to diseases such as heart attack, angina or stroke.
The study period per participant is 3 months spanning 2 visits at Queen Alexandra Hospital in Cosham. Each visit is expected to last approximately 3 hours. On the day of their visit participants will undergo physical examination, blood and urine sampling and assessment of endothelial function. The endothelial function is assessed using photoplethysmography a non-invasive technique using a finger probe attached to a specialist machine. Participants will be randomly allocated to receive placebo or Vitamin D capsule once daily for 12 weeks. The investigations will be repeated at the end of intervention period.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0073
Date of REC Opinion
18 Feb 2015
REC opinion
Favourable Opinion