Effect of Jianpi Qinghua Decoction on Gut Microbiota, Intestinal Permeability and Glycolipid Metabolism in Newly Diagnosed T2DM Patients: Study Protocol for a Randomized, Double-blind, Placebo-controlled Clinical Trial

Background The gut microbiome is a key target for traditional Chinese medicines (TCM) to ameliorate type 2 diabetes mellitus (T2DM). Patients with T2DM have quite distinct gut microbiota in comparisons with normal individuals, and it directly influences intestinal permeability. This study aims to investigate the underlying effects of Jianpi Qinghua Decoction on gut microbiota and intestinal permeability in newly diagnosed T2DM patients. Methods / design This study is a single-center, randomized, double-blind, placebo-controlled clinical trial in 120 subjects with newly diagnosed T2DM. The patients will be randomized in a 1:1 ratio into placebo group (1/10 Jianpi Qinghua Decoction + maltodextrin twice daily, n = 60) and treatment group (Jianpi Qinghua Decoction twice daily, n = 60). The study drugs will be double blinded to both investigators and participants. The visits will be done at baseline (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3). Measures include: anthropometric measures, blood pressure, glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2hPG) and serum insulin, total cholesterol (TC), total triglycerides (TG), low-density lipoprotein cholesterol (LDL) and high-density lipoprotein cholesterol (HDL), safety indexs (including blood routine examination, clinical urine tests, liver/renal profile), identifying intestinal permeability used ELISA testing serum LPS, serum intestinal fatty acid binding protein (IFABP), serum Zonulin concentrations and fecal sample collection for gut microbiota profiling through 16S rRNA gene sequencing. Data will be analyzed using SPSS version 26. Discussion We describe a clinical research protocol evaluating the impact of Jianpi Qinghua Decoction on gut microbiota and intestinal permeability in newly diagnosed T2DM patients. We assume that adminstration of Jianpi Qinghua Decoction will correct gut microbial dysbiosis and intestinal permeability, leading to improved glycemic control. Trial registration Chinese clinical trial registry, identifier: ChiCTR2000039423（http://www.chictr.org.cn/edit.aspx?pid=62537&htm=4.）.Registered on 27 October 2020.