EFFECT OF LIRAGLUTIDE ON CAROTID INTIMA-MEDIA THICKNESS IN OBESE PATIENTS WITH TYPE 2 DIABETES- INTERIM ANALYSIS OF AN ONGOING 9 MONTHS PROSPECTIVE STUDY.

BACKGROUND:
Liraglutide a GLP-1 analogue exerts several beneficial non-glycemic effects in patients with type 2 diabetes, such as those on body weight, blood pressure, plasma lipids and inflammatory markers. However, there are no major trials showing the effect of liraglutide on subclinical atherosclerosis in diabetic subjects with metabolic syndrome, while few pilot studies do demonstrate its favorable effect in terms of carotid intima-media thickness(IMT) reduction, a recognized marker of subclinical atherosclerosis.
AIMS:
1.	To assess the effect of Liraglutide on the common carotid intima-media thickness in obese patients with type 2 diabetes.
2.	To assess the effects of Liraglutide on biochemical and anthropometric parameters.
METHODS:
This is a 9 months’ prospective study intended to assess the effect of Liraglutide on carotid intima-media thickness. 200 obese patient with uncontrolled type 2 diabetes and no prior history of coronary artery disease were recruited, 100 didn’t receive liraglutide and 100 patients received liraglutide to the existing regimen, started with 0.6mg/day and up-titrated to 1.8mg /day in 3 weeks. B mode real-time ultrasound was performed at baseline, 3 and 9 months and the thickness of the arterial wall of the common carotid arteries was evaluated. Body impedance analysis (BIA) was done and noted for every patient and along with that, the anthropometric and biochemical parameters were also recorded.
 This is an ongoing trial and so far, 45 patients have completed the study in liraglutide arm and very few in the non-liraglutide arm. An interim analysis has been done on liraglutide arm as it involves significant cost, resources and to look for any need for amendments if necessary.

RESULTS:
45 patients completed the study, 29 were females and 16 were males, their mean age was 42.8 years. During this study, HbA1C decreased by 1.6% at 3 months and by 1.3% at 9 months, weight decreased by 6.4 kg (p Value<0.05 ) at 3 months and 6 kg by 9 months. Waist circumference decreased by 7.3 cm (p-value <0.05) in 3 months and 8.4cm at 9 months. The analysis of BIA showed that there was a reduction in the fat mass by 5.1 kg (p-Value <0.05) at 3 months and 5.7 kg at 9 months. The carotid IMT decreased by 1 mm at  (p-Value <0.05) 3 months and 0.7 mm at 9 months. The changes in the lipid levels were not statistically significant.

DISCUSSION:
Liraglutide decreases carotid IMT at 3 months of therapy and maintained until 9 months of treatment independent of effects on plasma glucose and lipids concentration. The initial few months of initiation of liraglutide has a maximal beneficial effect which is well maintained later. While reduction of the carotid IMT has a statistical significance, which can be correlated with few other studies demonstrating similar outcome, the addition of the statistical analysis of the control group will add more value to the existing data which lacks in other studies.

Effect of liraglutide on carotid intima-media thickness in obese patients with type 2 diabetes: interim analysis