Glycaemic and insulinaemic impact of a diabetes-specific oral nutritional supplement with extra-virgin olive oil in patients with type 2 diabetes mellitus at nutritional risk: a randomized, double-blind, crossover, multicentre clinical trial (DIACARE)

Introduction: there is controversy about the usefulness of specific enteral nutrition formulas in malnourished patients with diabetes. The effects on blood glucose and other aspects of metabolic control are not fully understood in the scientific literature.Objective: the aim of the study was to compare the glycaemic and insulinaemic response of patients with type 2 diabetes at risk of malnutrition after oral feed between a diabetes-specific formula with AOVE (DSF) and a standard one (STF). Methods: a randomized, double-blind, crossover, multicentre clinical trial was conducted in patients with type 2 diabetes at risk of malnutrition (SGA). The patients were randomized to receive either DSF or STF, a week apart. A glycaemia and insulinaemia curve was made at times 0 minutes, 30 min, 60 min, 90 min, 120 min, and 180 min after the patients drank 200 ml of the oral nutritional supplement (ONS). The principal variables were the area under the curve (AUC0-t) of glucose and insulin. Results: 29 patients (51 % women) were included, who were on average 68.84 (SD 11.37) years old. Regarding the degree of malnutrition, 86.2 % presented moderate malnutrition (B) and 13.8 % severe (C). When the patients received the DSF, they had a lower mean of glucose AUC0-t (-3,325.34 mg/min/dl [95 % CI:-4,3608.34 to-2,290.07]; p = 0.016) and also a lower mean of insulin AUC0-t (-451.14 mu U/min/ml [95 % CI:-875,10 to-27.17]; p = 0.038). There were no differences in the degree of malnutrition.Conclusion: compared with STF, DSF with AOVE showed a better glycaemic and insulinaemic response in patients with type 2 diabetes at risk of malnutrition.