Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study

Background and aimsIn type 2 diabetes (T2D) patients, the reduction of glycemic variability and postprandial glucose excursions is essential to limit diabetes complications, beyond HbA1c level. This study aimed at determining whether increasing the content of Slowly Digestible Starch (SDS) in T2D patients’ diet could reduce postprandial hyperglycemia and glycemic variability compared with a conventional low-SDS diet.Methods and resultsFor this randomized cross-over pilot study, 8 subjects with T2D consumed a controlled diet for one week, containing starchy products high or low in SDS. Glycemic variability parameters were evaluated using a Continuous Glucose Monitoring System.Glycemic variability was significantly lower during High-SDS diet compared to Low-SDS diet for MAGE (Mean Amplitude of Glycemic Excursions, p < 0.01), SD (Standard Deviation, p < 0.05), and CV (Coefficient of Variation, p < 0.01). The TIR (Time In Range) [140–180 mg/dL[ was significantly higher during High-SDS diet (p < 0.0001) whereas TIRs ≥180 mg/dL were significantly lower during High-SDS diet. Post-meals tAUC (total Area Under the Curve) were significantly lower during High-SDS diet.ConclusionOne week of High-SDS Diet in T2D patients significantly improves glycemic variability and reduces postprandial glycemic excursions. Modulation of starch digestibility in the diet could be used as a simple nutritional tool in T2D patients to improve daily glycemic control.Registration numberin clinicaltrials.gov: NCT 03289494.     

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??Objective    To investigate the influence of Bushen Zhuanggu Decoction on the bone healing after teeth extraction in osteoporotic dogs. Methods    Totally 9 female adult dogs whose bilateral ovaries were surgically removed to establish osteoporosis models were randomly divided into 3 groups ??control group??Western medicine group and traditional Chinese medicine group??. Bilateral mandibular premolars were extracted 3 months after castration. Osteoporosis treatment was started the third day after tooth extraction. The dogs in the traditional Chinese medicine group??the Western medicine group and the control group were respectively fed with Bushen Zhuanggu Decoction??Estradiol Valerate Tablets and nothing. The bone mineral density??BMD?? value of dog′s lumbar spine and mandible of each group were detected before and after 3 months of castration and 3 months after teeth extraction. The tissue morphology of the mandible was observed at 1??2 and 3 months after teeth extraction. Results    Three months after teeth extraction??the BMD values of the lumbar spine and mandible in the traditional Chinese medicine group and the Western medicine group were significantly increased compared with those before the osteoporosis treatment??and there was no significant difference compared with the preoperative ones. One month after teeth extraction?? the new bone and the trabecular bone were observed in irregular patterns in the control group and the Westen medicine group??and those were arranged in a mesh pattern in the Chinese medicine group. Two months after teeh extraction??the trabecular bone structure was sparse in the control group??the Western medicine group was more than that of the new bone??and the number of trabecular bone in the Chinese medicine group was more robust. Three months after teeth extraction??the bone trabecular structure was relatively compact in the control group and the gap is small??the new bone tissue and the original bone tissue roughly fused together in the Western medicine group??the new bone tissue of the traditional Chinese medicine group was more similar to the structure of the original bone. Conclusion      Bushen Zhuanggu Decoction can make cancellous bone around the teeth extraction of the osteoporosis canine and significantly increase the amount of bone tissue??so as to promote bone reconstruction and bone healing after teeth extraction.     

Mixing is required for uniform reconstitution of filter-dried protein antigens in a single-injection vaccine formulation

Ambient temperature filter dried vaccine formulations have been proposed to simultaneously achieve thermostability and offer a ready-to-use immunisation device that combines reconstitution and injection. Vaccine concentration should be uniform at the point of injection, but the uniformity following direct reconstitution of filter-dried vaccines has not been reported. We present here a study of vaccine mixing and release following dissolution of filter-dried model protein and toxoid antigens within a single syringe, filter and needle unit. Release was better for filters made from glass than cellulose. Without additional mixing, uniformity was poor and only 41% of input protein was released from protein filter-dried onto glass fiber. In contrast, adding a simple glass bead and mixing by inversion, 100% release antigen solution was achieved, with uniform concentration at exit from the needle throughout a simulated injection. Adsorption onto alum adjuvant had no detectable effect on vaccine dissolution and mixing. The uniformity and yield of low doses of diphtheria and tetanus toxoid was also improved by mixing, albeit with a lower yield of 60–68%. We conclude that uniformity and mixing should be studied to ensure safety and efficacy of directly reconstituted filter-dried vaccine formulations.     

The incorporation and release of glucose oxidase and interleukin 2 from a bead formed macroporous hydrophilic polymer matrix

Freeze-thaw photopolymerization at low temperature of a mixed solution of 2-hydroxyethyl methacrylate (HEMA), ethylene glycol dimethacrylate (EDM), and either glucose oxidase (GOx) or interleukin 2 (IL-2) around frozen ice crystals has been used to generate a bead-formed macroporous hydrophilic matrix with potential for immobilization and sustained release. The mean equilibrium acetate buffer content (EBC) of unloaded p-HEMA beads at room temperature and controlled humidity was ~72%. The incorporation of GOx into beads significantly increased the EBC to ~76%. The release of GOx was characterized by a short initial burst release which declined rapidly until by day 14 no further biologically active enzyme release could be detected. Bead size had no significant effect on the total mean cumulative release of GOx at room temperature. Since only ~ 4% of the original therapeutic load of GOx was released over 14 days a substantial proportion of biologically active enzyme had become associated with the hydrogel matrix surface generating a bead formed immobilised enzyme system. Total cumulative release profiles for IL-2 were almost linear and maintained for at least 16 days. In absolute terms, the proportion of the original theoretical incorporated load subsequently released over this period was low. However, such a low level sustained release of IL-2 may lend itself therapeutically to a reduction in unwanted non-specific systemic activity.