NCT04287387

Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, T2DM patients who were free of anti-diabetic drugs or those have taken hypoglycemic drugs and ready to add a new drug were recruited, they were treated with metformin, α - glucosidase inhibitor, DPP-4 inhibitors, sulfonylureas, SGLT-2 inhibitors, or thiazolidinediones according to their state of illness. Faecal specimen will be collected for test of composition of gut microbiota at baseline and 4-week, 8-week，12-week after taking medication. At baseline, patients will take physical examination and blood test, every patient will complete the questionnaire under the direction of doctors to get their general information and diet habits. Physical examination and blood test will repeat at 4-week, 8-week，12-week after treatment.

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Glucophage 500Mg Tablet	0.5g three times daily
DRUG	Acarbose Tablets	50mg three times daily
DRUG	Sitagliptin tablet	100mg once daily
DRUG	Dapagliflozin Tablet	10mg once daily
DRUG	Pioglitazone Tablets	30mg once daily
DRUG	Glimepiride Tablets	2mg once daily

Timeline

• Start date: 2020-03-02
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2020-02-27
• Last updated: 2020-02-27

Locations

1 site across 1 country: China