CGMS
A total of 39 volunteers (26 male and 13 female) were
recruited to the CGMS sub-study. Baseline characteristics
for all participants who completed both baseline and 12
month CGMS measurements were similar and not significantly
different from the main group of volunteers. Results
are reported for the 29 volunteers who completed all
measurements.
The 24 h average blood glucose decreased significantly
with time (p Z 0.001) by 1.6 0.5 and 0.7 0.4 mmol/L in
HPD and SPD respectively at 4 months. Between 4 and 12
months the 24 h BG increased and was not different from
baseline in either group. Adjusting for baseline values
revealed a treatment effect at 4 months (p Z 0.023) but
not at 12 months (p Z 0.12).
%T > 10 decreased significantly between baseline and 4
months (p Z 0.003). The HPD group decreased from 22%
to 6% (relative change 73%) and the SPD group decreased
from 19% to 10% (relative change 47%) with no significant
treatment effect. At the end of the study %T > 10 was not
significantly different from baseline (HPD 16% and SPD
20%).
At 4 months Gmax had decreased by 2.2 1.1 HPD and
1.1 1.0 mmol/L SPD (p Z NS adjusted for baseline). Gmax
increased between 4 and 12 months and did not differ
significantly from baseline. AUC decreased in HPD by 2155
and in SPD by 1004 (mmol/L/min) p Z 0.001 for time. AUC
increased in both groups between 4 and 12 months and
was no longer significantly different from baseline.
Adjusting for baseline values there was no significant effect
of treatment at 12 months.
The change in AER was significantly correlated with the
change in Gmax at 12 months (r Z 0.389; p Z 0.037) but
after adjusting for baseline AER and weight loss (r2Z0.57;
p Z0.028); change in Gmax was not significant (pZ0.14).
All CGMS variables were strongly correlated with HbA1c at
both 4 and 12 months (Gmax r Z 0.574, p Z 0.001; %
T > 10 r Z 0.695, p < 0.00; AUC r Z 0.692, p < 0.00; mean
24 h BG r Z 0.651, p < 0.00 at 12 months). SBP was
significantly correlated with 24 h BG (r Z 0.38; p Z 0.04)
at 4 months but not at 12 months.