drugset / Trial / NCT04287387

Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents

NCT04287387

RandomizedParallel-groupOpen-labelTreatment

Summary

Intestinal microflora refers to the trillions of microorganisms living in our gut, which is considered as an independent endocrine organ of human body. Intestinal microbiota plays a very important role in human health. The composition of human intestinal microbiota is affected by a variety of factors, including age, living region, eating habits, nutrition, probiotics, antibiotics and so on. It is found that the imbalance of intestinal microbiota is closely related to the occurrence and development of metabolic diseases including type 2 diabetes mellitus (T2DM). There are great differences in the structure and function of intestinal microbiota between healthy people and T2DM patients, and recently changes of intestinal microbiota have been observed in pre-diabetes. In recent years, it has been found that some commonly used hypoglycemic drugs may regulate and improve the imbalance of intestinal flora of T2DM patients, including metformin, α - glucosidase inhibitor, and Glucagon-like peptide-1(GLP-1) receptor agonist, which have a positive impact on the short chain fatty acid (SCFAs) producing bacteria. However, on the one hand, subjects of those studies were mostly western population and there were just a few studies on the influence of anti-diabetic drug on human gut microbiota in Chinese population, on the other hand, the study of influence of Dipeptidyl peptidase-4(DPP-4) inhibitors, sulfonylureas, sodium-dependent glucose transporters-2(SGLT-2) inhibitors or thiazolidinediones on intestinal microbiota is rare or even absent. This study aims to explore the effect of different hypoglycemic drugs on intestinal flora and find the potential intestinal target of drug action in Chinese population.

Timeline

Start
2020-03-02
Primary completion
2021-03-02
Completion
2021-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Acarbose Unknown 50 mg
Subject Dapagliflozin Small molecule 10 mg
Subject Glimepiride Small molecule 2 mg
Subject Metformin Small molecule 0.5 g
Subject Pioglitazone Small molecule 30 mg
Subject Sitagliptin Small molecule 100 mg