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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04426422

Enrollment

Registered

2020-06-11

Start date

2017-03-01

Completion date

2018-09-30

Last updated

2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

DRUGMetformin Hydrochloride

treated with metformin 1500-2000mg daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

newly diagnosed type 2 diabetes was treated with metfomin for 3 months.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
gut micribiota	3 months	the changes of gut micribiota

Secondary

Measure	Time frame	Description
glycemic control	3 months	HbA1c

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026