The effects of alcohol consumption on cardiovascular risk in patients with type II diabetes mellitus

During an initial 4-week run-in period, patients continue their usual regular alcohol intake and complete baseline assessment of their usual dietary and drinking patterns. They are then be randomized into a 3 period cross-over study of Latin square design, during which they consume during sequential 4-week study periods:- (1) alcohol as red wine (a shiraz cabernet blend of known composition and alcohol content - alcohol 13% v/v, sourced from Orlando Wyndham, Rowland Flat, South Australia) (a) in women: 20-30 g/day – approx. 140-210 g/week. (2-3 bottles/week with a minimum consumption of 20 g/day every day and maximum consumption of 30 g/day every day). (b) in men: 30-40 g/day – approx. 210-280 g/week (3-4 bottles/week with a minimum consumption of 30 g/day every day and maximum consumption of 40 g/day every day). or (2) an identical red wine but which has been de-alcoholised (again sourced from Orlando Wyndham, Rowland Flat, South Australia), consumed in equivalent volumes daily to the regular alcohol period. During this 4-week period they otherwise remain abstinent from all alcohol. or (3) water. During this 4-week period they will otherwise remain abstinent from all alcohol. The precise amount of red wine and de-alcoholised red wine within the above ranges is dictated by subject's usual alcohol intake at entry to the study. There was no washout period between each 4-week study period. All measurements are performed at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period. BP and heart rate are measured using 24-hour ambulatory BP measurements; glucose, insulin, lipids and lipoproteins are measured in fasting blood samples. Compliance with the designated changes in alcohol intake are recorded by 7-day retrospective weekly diaries, completed at weekly visits to the clinical trials unit. In addition serum is sampled at the end of the 4-week run-in period and the end of each subsequent study period for both gamma-glutamyl transpeptidase and carbohydrate deficient transferrin as biomarkers of alcohol intake. Twenty-four hour urinary 4-O-methylgallic acid is determined as a biomarker of red wine intake.