Almost-Experimental Study: Complementary feeding with lupinus mutabilis Sweet in patients with diabetes-mellitus-2

Type 2 diabetes mellitus (DM-2) is a serious health problem in Ecuador and in the world, due to its high prevalence, the serious tissue damage caused in time and its high socioeconomic impact. Maintaining glucose within a physiological range in patients is vital to limit tissue damage that is associated with high morbid mortality. Our studies have shown that the consumption of a lupinus mutabilis Sweet snack, known as Chocho in Ecuador, decreases glucose and improves insulin sensitivity in patients with DM-2. The complementary consumption of this snack can be a low cost option to limit the tissue damage caused by the DM-2. Objective: Compare the control of the DM-2 between the conventional treatment of DM-2 with that of another that combines the conventional treatment plus a lupinus mutabilis Sweet Termpic Methods: an almost-experience-experienced study with cross-out-of-dested design will be carried out. The evaluators and the data analyst will be blinded in relation to the type of treatment that patients receive. The primary outcome is the change in the value of glycosylated hemoglobin (A1C). Patients who regularly attend the Diabetes Club of the Pauta Hospital of the Ministry of Public Health and the Diabetes Club of the General Teaching Hospital of the city of Riobamba through the National University of Chimborazo (UNACH) will be enrolled. Initially, the 90 patients with DM-2 with an evolution not exceeding 7 years since their diagnosis and without severe complications of their disease will be taken their basal data, they will be maintained with the usual treatment prescribed by their doctor for 14 weeks. After this period, patient data will be measured again and will continue with the usual treatment plus a lupinus mutabilis Sweet snack for 14 weeks; After which the study variables will be measured again. The primary outcome point is the change in A1C during the study. The secondary outcomes will be: a) % of patients that reach a level of A1c = 7.4 %, b) the % of patients that reach an emptyneous glucose = 125 mg/dl, c) the change in the insulin value, d) the change in the lipid profile, e) the change in anthropometric measures, f) the change in blood pressure, g) the change in the change in the protein c) In liver transaminases. 90 patients are required in total. Descriptive statistics will be performed. In the case of normal distribution, anova and test of apparent T will be used, in case it is not normal distribution, the Kruskal Wallis statistics and the Wilcoxon Signed Ranks are used. This protocol will be approved by the UTE Bioethics Committee and patients will sign an informed consent.

OUT OF CALL – EXTERNAL FUNDS