Effects of An Enteric-protective Capsule on ? Cell Function in Patients With LADA

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Latent autoimmune diabetes in adults (LADA) is actually a form of type 1 diabetes, which is caused by autoimmune damage of islet ? cells and triggered by environmental factors based on genetic susceptibility. The goals of treatment for LADA are alleviation of autoimmune ? cell destruction, preservat...

Latent autoimmune diabetes in adults (LADA) is actually a form of type 1 diabetes, which is caused by autoimmune damage of islet ? cells and triggered by environmental factors based on genetic susceptibility. The goals of treatment for LADA are alleviation of autoimmune ? cell destruction, preservation of islet function and prevention of diabetic complications. Insulin has been used as a routine therapy for LADA to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of ? cell or preserve its function. Stachyose is a naturally functional oligosaccharide and acts as prebiotics, that can shift gut microbiota with beneficial effects on host health. Berberine, a small alkaloid isolated from medicinal plants, has been reported to have many therapeutic effects, including anti-bacteria, anti-diabetes, and lipid-lowering. Besides, studies revealed that berberine exerts antidiabetic effects by modulating gut microbiota. In a multicentre, randomized, double-blinded, placebo-controlled 12-week clinical trial conducted in 409 drug-naive T2D patients, Wang et al. confirmed the hypoglycaemic effect of berberine in Chinese participants and demonstrated the berberine-induced changes in the human gut microbiome in comparison with the placebo. Moreover, Ho et al. conducted a randomized, placebo-controlled trial in 38 children with type 1 diabetes using placebo or prebiotic oligofructose-enriched inulin for 12 weeks, and found that oral supplement of the prebiotic could improve glycemic control and ? cell function. So we speculate that berberine and stachyose combination can also protect the islet ? cell function in the patients with LADA. This is a single-center, double-blind, 1:1 randomized controlled trial to investigate the effects of berberine and stachyose combination in LADA patients previously treated with insulin. The study comprises twice screening, the 1-month run-in period, the 3-month treatment period and the 9-month follow-up period. The first screening is to choose the LADA patients from the diabetes patients whose disease duration < 5 year. After obtaining the informed consent from the patient who is willing to participate the 3-month treatment will enter to the 1-month run-in period. The second screening will find out the eligible patients from the 1-month run-in period according to the inclusion/exclusion criteria, then the patients will be randomized to the 3-month treatment period. Patients will be randomized into two groups through simple randomization: insulin+berberine and stachyose combination, insulin+placebo. Glucose parameters, ? cell function and gut microbiota, as well as gastrointestinal side effects and hypoglycemia events will be monitored.

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