Background:
Type 2 diabetes mellitus (T2DM) complicated with dyslipidaemia is associated with a high risk of
cardiovascular diseases. The Jiangtang Tiaozhi (JTTZ) recipe is a Chinese herbal formula that has been used to regulate the
blood glucose and
lipid levels for many years. Interestingly, a previous study has demonstrated its efficacy; however, the associated mechanism remains unclear. We hypothesised that the
therapeutic effect of the JTTZ on patients with T2DM may be mediated by the modulation of metabolites secreted by the gut microbiota. This study aims to examine this mechanism. Methods and analysis: This study is a randomised, positive
drug parallel-controlled, open-label clinical trial in patients with T2DM and dyslipidaemia. A total of 96 patients will be recruited and randomly assigned to treatment with JTTZ or
metformin for 12 weeks. The primary outcome will be the rates of effectively regulated
blood glucose and
lipid levels (measured with the levels of glycated haemoglobin, fasting plasma
glucose, 2-h plasma
glucose,
triglyceride, and
low-density lipoprotein cholesterol). The secondary outcomes will be the changes in
body weight, body mass index, and waist circumference and
Traditional Chinese Medicine symptom scores. In addition,
16S rRNA gene sequencing will be performed on the gut microbiota obtained from faeces, and metabolomics analysis will be performed based on blood and gut microbiota samples. Intention-to-treat, per-protocol analysis and safety analysis will be performed. Clinical trial registration number: https://clinicaltrials.gov/ct2/show/NCT04623567.