Endocrine Abstracts

Introduction and Objectives: The prevalence of prediabetes in the adult Spanish population is close to 15%. People with prediabetes are not only at high risk of developing T2DM but also at high cardiovascular risk. Several drugs, including metformin, glitazones, GLP-1RAs and SGLT2is have been found to reduce the incidence of diabetes in this population, but none is currently licensed with this indication. In particular α-glucosidase inhibitors such as acarbose have been shown to significantly reduce the risk of progression to T2DM but also the risk of developing hypertension and major cardiovascular events (STOP-NIDDM trial). The white mulberry (Morus Alba) leaf contains 1-deoxynojirimycin, a powerful α-glucosidase inhibitor. A novel neutraceutical based on Reducose, a patented standardized white mulberry leaf extract, containing also fenugreek, inulin, Lactiplantibacillus plantarum A14, chromium, zinc and niacin (for better efficacy and tolerance) has been developed for the treatment of prediabetes. We undertook an open trial to validate the tolerability and efficacy of this nutraceutical including markers of cardiovascular and metabolic risk.

Methods: We are actively recruiting adult subjects with prediabetes, excluding those with morbid obesity, concomitant serious diseases, alcoholism, addictions, present or planned pregnancy. After obtaining baseline anthropometry and lab tests and giving informed consent, they take a pill of the nutraceutical daily before lunch with a glass of water. Follow- up visits are scheduled after 3-4 and 6-7 months. Presently we have 15 subjects who have completed the first follow-up visit for this preliminary analysis. The targets are: estimated 10-year cardiovascular risk (SCORE2), lipid profile, systolic BP, BMI, fasting glucose and insulin, HOMA2-IR and tolerability (questionnaire). Stats were made by paired t-test.

Results: In 15 subjects (2/3 women, age 54.2±6.6 years, 20% active smokers), the SCORE2 changed from to 4.09±1.98 to 3.63±1.83% (P=0.002); cHDL from 46.5±9.5 to 49.1±8.9 mg/dl (P=0.002), triglycerides from 183.6±59.4 to 155.9±52.8 mg/dl (P=0.009); SBP from 138.1±16.1 to 131.7±13.4 mmHg (P=0.002); HOMA2-IR from 1.42±0.32 to 1.19±0.17 (P=0.029); fasting glucose from 105.5±11.9 to 99.5±7.7 mg/dl (P=0.015); fasting insulin from 10.6±2.4 to 8.89±1, 31 μU/ml (P=0.028); HbA1c from 6.07±0.28 to 5.93±0.24% (P=0.023). Total cholesterol, cLDL and IMC did not change significantly. There were no serious tolerability issues and no patient has withdrawn from the study so far.

Conclusions: These are very preliminary but promising results for the novel neutraceutical with significant reductions both for cardiovascular and for metabolic risk.