Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin Hydrochloride

• Registration Number: NCT04426422
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.

Detailed Description

This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were collected at the beginning and 3 months later.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

newly diagnosis type 2 diabetes ,HbA1c >7 %

Exclusion Criteria

history of cardiovascular disease, hypertension, severe renal dysfunction defined as glomerular filtration rate < 45 mL/min/1.73 m2; severe illness or diabetic ketoacidosis within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
metformin group	Metformin Hydrochloride	all the patients were treated with metformin 1500-2000mg daily for 3 months.

Primary Outcome Measures

Name	Time	Method
gut micribiota	3 months	the changes of gut micribiota

Secondary Outcome Measures

Name	Time	Method
glycemic control	3 months	HbA1c

Trial Locations

Locations (1)

Shenzhen People' S Hospital; 🇨🇳 Shenzhen, Guangdong, China