Abstract:
Abstract
Background A woman with a history of GDM has a high risk of developing type two diabetes (T2DM) in her future
life. Lifestyle modifications are known to attenuate the progression of GDM to T2DM. Therefore, the aim of this study
was to assess the impact of a simple, cost effective, culturally acceptable lifestyle intervention programme on the
trajectory towards T2DM in women with a history of GDM.
Methods This cluster randomized trial was conducted in 100 postpartum women in three selected districts of Sri
Lanka. The subjects were divided into intervention (n=50) and control groups (n=50) by cluster randomization
method. A culturally adapted protocol (comprised of dietary and physical activity modifications) was administered to
the intervention group. The glycemic profile was assessed using fasting and 2-hour post-OGTT plasma glucose and
HbA1c, and insulin resistance by HOMA-IR at baseline and after one year of intervention.
Results The mean age (SD) of the subjects in the intervention and control groups were 33.0 (5.1) and 34.3 (6.5)
years respectively. All glycemic and insulin resistance parameters (i.e. Fasting plasma glucose- FPG, 2-hour postOGTT plasma glucose, HbA1c and HOMA-ir) were comparable (p>0.05) between the two groups at baseline. FPG,
2 h post OGTT, HbA1c and HOMA-ir values between intervention vs. control (p) at 12 months were 87.3 vs. 123.2
(<0.01); 106.5 vs. 156.1 (0.01); 5.3 vs. 6.8 (<0.01) and 0.9 vs. 2.3 (<0.01) respectively. All glycemic parameters showed
a significant reduction in the intervention group at 12 months compared to baseline. In contrast, the control group
showed a significant increase in FPG, 2-hour post-OGTT plasma glucose and HbA1c at 12 months compared to
baseline. In multiple linear regression model adjusted for age, parity and family history, the control group showed an
approximately 33 times risk of developing insulin resistance compared to the intervention group