Executive Summary: Type 2 diabetes mellitus (DM2) is a serious health problem in Ecuador and in the world, due to its high prevalence, the serious tissue damage it causes over time and its high socio-economic impact. Maintaining glucose within a physiological range in patients is vital to limit tissue damage that is associated with high morbidity and mortality. Our studies have shown that the consumption of a Lupinus mutabilis Sweet snack, known as chocho in Ecuador, lowers glucose and improves insulin sensitivity in patients with DM2. The administration of this snack may be an effective and low-cost option to limit tissue damage as an adjunctive treatment for DM2.
Initially, the 90 patients with DM2 with an evolution of no more than 7 years since their diagnosis and without severe complications of their disease will have their baseline data taken, they will be maintained with the usual treatment prescribed by their doctor for 14 weeks. After this period, the patients' data will be measured again and they will continue with their usual treatment plus a snack of Lupinus mutabilis Sweet for 14 weeks; after which the study variables will be measured again. The primary end point is the change in A1c during the study. The secondary endpoints will be: a) the % of patients reaching an A1c level ≤ 7.4%, b) the % of patients reaching a fasting glucose ≤125 mg/dL, c) the change in the value of insulin, d) change in lipid profile, e) change in anthropometric measurements, f) change in blood pressure, g) change in C-reactive protein h) change in liver transaminases. A total of 90 patients are required. Descriptive statistics will be made. In the case of a normal distribution, ANOVA and the paired t test will be used; if it is not a normal distribution, the Kruskal Wallis statistics and the Wilcoxon Signed Ranks paired test will be used. This protocol will be approved by the bioethics committee of the UTE and the patients will sign an informed consent.
General Objective: To compare the efficacy of metabolic control of patients with DM2 of conventional treatment with that of another that adds a Lupinus mutabilis Sweet snack to conventional treatment.
Specific objectives:
- To compare the efficacy of usual treatment for DM2 with that of usual treatment plus the addition of two L. mutabilis Sweet snacks in terms of absolute value of glycosylated hemoglobin (A1c) and the percentage of patients achieving ideal metabolic control as determined by a A1c value ≤7.4 at 4 months.
- Compare changes in lipid profile between groups and within study groups at 4 months.
- To compare changes in anthropometric measurements and in systolic and diastolic blood pressures between groups and within study groups at 4 months.
- Compare changes in C-reactive protein between groups and within study groups at 4 months.
Participating Institutions:
UTE, UC, UNACH
Participants:
Project Manager Marco Fornasini, MD, PhD
- Marco Fornasini, MD, PhD
- Victoria April
- Jose Patricio Beltran Carreno
- Francisco Robalino
- Lourdes Square Merino
Awarded budget: $38540
Project status: In progress.
