Medication
Four volunteers managed their diabetes with diet alone; all other volunteers were treated with oral BG lowering medication and/or insulin. All volunteers were treated
with blood pressure lowering medication and all except
two were treated with statins.
Medication was adjusted to optimized glycaemic control, BP and serum lipids by an endocrinologist before the start of the study and monitored throughout the study.
The volunteers own doctors also monitored them and made medication changes. All participants reported a moderate to low physical exercise level and they were
asked to maintain this level throughout the study (see supplementary data Appendix 2 for changes in medication).
Statistical analysis
Differences between randomized groups were tested at baseline using independent samples T-test. An analysis of covariance (ANCOVA) was used to compare the post-test
variables using the pre-test values as covariates. Data are presented as mean (SEM). Significance is assumed with a p-value less than 0.05 (see supplementary data
Appendix 3).
Results
76 volunteers commenced the study. 45 participants (35 men and 10 women) completed the one year dietary intervention (21 HPD and 24 SPD), and were included in the analysis.
Metabolic control was similar between groups at
baseline (Table 1). The groups differed only in the degree of AER, which was higher in the SPD compared to HPD.