Abstract

Nanoparticles play a major role in drug delivery. We investigated the effects of the intelligent administration of insulin-loaded nanoparticles (ILNP) when combined with a low-carbohydrate diet (LCD) on the metabolism of patients with type 2 diabetes. ILNP and smart vesicle polymers were developed, and their properties were studied in vitro. Further clinical trials were performed, during which body mass index (BMI), fasting blood glucose (FBG) levels, and glycated hemoglobin (HbA1c) levels were compared between type 2 diabetes patients on LCDs those on normal diets. The results demonstrated that ILNP resisted protease degradation due to steric hindrance, and remained relatively stable at a pH range of 5.0 to 7.4. The nanoparticle enteric-coated capsules resisted the gastric juice acidity (pH = 2.5) and ensured the stable embedding of the insulin. The insulin was then released at a slightly higher pH (pH = 6.6), which mimicked the small intestine. Smart vesicle polymers further embedded the insulin and glucose oxidase simultaneously in nano polymer compounds, which allowed for a dose-dependent response to the concentration of glucose. Thus, the insulin was not released in a low-concentration glucose solution, but rather in a high-concentration glucose solution. Based on these results, we concluded that the clinical trial results showed that the intelligent administration of ILNP combined with a LCD reduced BMI, FBG, and HbA1c levels in patients with type 2 diabetes.

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