Utility of low glycaemic index of rice in the management of type 2 diabetes: randomized cross-over trial on glycemic control, related parameters and quality of life

India has high burden of type 2 diabetes mellitus (T2D). Glycemic control is important to reduce chronic micro vascular complications. Though lifestyle intervention, dietary changes, and drug therapy are important, quality of life should be maintained by not restriction their long held dietary practices. In practice, patients often request rice for at least once a day in meals to maintain pleasure of eating. However, rice is considered carbohydrate rich worsening glycemic control. We would assess the effect of rice with low glycemic index (GI) on glycemic control, related parameters i.e., insulin, lipids and quality of life in T2D. The study will be carried out in a step wise manner. In stage 1 we would assess GI of 5 rice varieties (four with low and one with high GI) in healthy controls. Stage 2 would assess similar GI in T2D with HbA1c < 8.0%. Stage 3 would be a randomized crossover trial in T2D with intervention of regular intake of low GI rice in meal once per day for 3 months. An open labelled randomized cross-over trial would be carried out in type 2 diabetics with intervention of daily intake of fixed amount of rice with low glycemic index during lunch. After inclusion and exclusion criteria, 62 patients with T2D will be included. At enrolment a detailed history, physical examination including anthropometry, questionnaire on quality of life (SF36), days with dietary compliance in a month as per a visual analogue scale would be recorded. Blood glucose, Lipid profile, HbA1c, other standard investigation including complete blood count, liver and kidney function test would be done. Patients will be block randomized into Group 1 and 2. For first 3 months, group 1 would be advised cooked rice with best low GI as the essential meal in the lunch (covering 200 calories). Each subject in group 1 will be given 5 kg rice/every month for 3 months. To achieve total compliance the entire family supply of rice will be given. Group 2 will be instructed to continue with their regular diet pattern without rice for three months. After one month of wash over period, groups will be crossed with regard to intervention advise  i.e, group 1 will continue standard diet without rice and group 2 will be advised to take low GI rice during lunch for next three months. All subjects will be assessed for glycaemic status including glycated hemoglobin (HbA1c) and glucose moniting by free style Libre during the study period. Final assessment would be carried out at the end of seven months. All investigations which carried out at baseline will be repeated at their last follow-up visit.