TIDE In People With Type 2 Diabetes at Risk of Cardiovascular Disease
Research type
Research Study
Full title
Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease
IRAS ID
26599
Contact name
Simon Heller
Sponsor organisation
The GlaxoSmithKline group of companies
Eudract number
2008-005030-73
Clinicaltrials.gov Identifier
Research summary
Type 2 diabetes mellitus (T2DM) is a strong, independent risk factor for cardiovascular (CV) events and death. It is characterized by a history of hyperglycemia (high blood sugar) and reduced metabolic effectiveness of insulin (i.e. insulin resistance), and people with T2DM as well as those with impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) have abnormal fat distribution, renal function, lipid profiles, oxidative stress, platelet function, and many other changes. Emerging evidence also suggests that T2DM is associated with low vitamin D levels and a growing body of evidence links vitamin D deficiency to many of the chronic diseases that occur in people with diabetes. Evidence has also suggested a beneficial effect of vitamin D on the incidence of cancer. These observations suggest that thiazolidinediones (TZDs) and/or vitamin D therapy may reduce the risk of these diseases in high risk individuals.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
09/H0408/112
Date of REC Opinion
24 Feb 2010
REC opinion
Further Information Favourable Opinion