Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents

Registration

Registration

NCT04287387

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE4

Masking

NONE

Status

UNKNOWN

Enrollment

180

Start

2020-03-02

Primary completion

2021-03-02

Lead sponsor

Peking Union Medical College Hospital

Conditions

Type2 Diabetes Mellitus

Interventions

DRUG:Glucophage 500Mg Tablet; DRUG:Acarbose Tablets; DRUG:Sitagliptin tablet; DRUG:Dapagliflozin Tablet; DRUG:Pioglitazone Tablets; DRUG:Glimepiride Tablets

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in fasting blood glucose. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in level of TNF-a. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in fasting insulin. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in blood lipid including cholesterol, triglycerides, high-density lipoprotein. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in 2-hour postprandial blood glucose. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in level of IL-6. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in level of IL-8. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in level of IL-10. [Baseline, Week 4, Week 8, Week 12]
• Changes from baseline to post-treatment in composition in level of C-reative protein. [Baseline, Week 4, Week 8, Week 12]