Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04287387
Phase
PHASE4
Status
Unknown

Conditions

  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 2, 2020
Status verified
Feb 2020
Primary completion
Mar 2, 2021
Completion
Mar 2, 2021

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glucophage group
  • Experimental: Acarbose group
  • Experimental: Sitagliptin group
  • Experimental: Dapagliflozin group
  • Experimental: Pioglitazone group
  • Experimental: Glimepiride group

Primary Outcome Measure

Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing. [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

Central Contacts

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