Effect of intensive lifestyle modification & metformin on cardiovascular risk in prediabetes: A pilot randomized control trial

BACKGROUND & OBJECTIVES: Prediabetes is associated with increased prevalence of cardiovascular disease (CVD). In participants with prediabetes, the effects of exercise and metformin were evaluated on high-sensitivity C-reactive protein (hsCRP) and carotid intima-media thickness (CIMT), surrogate markers of atherosclerosis and CVD compared with standard care. METHODS: In a pilot randomized control trial, the participants were randomized in to three arms: standard care (STD), intensive lifestyle modification (ILSM) or ILSM and metformin (ILSM+Met) and followed up for six months. Monitoring of ILSM was done by a trained healthcare facilitator. hsCRP, CIMT and other relevant parameters were measured before and after intervention. RESULTS: A total of 103 participants were randomized into three arms and followed up for six months. At six months, there was a reduction from baseline in weight and fasting blood sugar (FBS) (P<0.01) in all three arms and a reduction in haemoglobin A(1c) (P=0.03) only in the ILSM+Met arm. The differences in hsCRP over six months within the STD, ILSM and ILSM+Met arms were −0.12 (95% confidence interval, −1.81, 2.08), −0.58 (−2.64, 0.43) and −0.11 (−1.84, 1.56), respectively. There was no difference in hsCRP, CIMT (right) or CIMT (left) between the three arms at six months. INTERPRETATION & CONCLUSIONS: There was a reduction in weight and FBS from baseline in all three arms. There was, however, no difference seen in hsCRP and CIMT in the two intervention arms compared to standard care. Larger studies with long-term follow up need to be done to detect differences in risk markers for CVD in prediabetes.