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NCT04426422 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04426422
Other study ID # GUTT2DM
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 1, 2017
Est. completion date September 30, 2018

Study information
Verified date June 2020
Source Shenzhen People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date September 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin Hydrochloride
treated with metformin 1500-2000mg daily

Locations
Country Name City State
China Shenzhen People' S Hospital Shenzhen Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary gut micribiota the changes of gut micribiota 3 months
Secondary glycemic control HbA1c 3 months
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