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

NCT ID: NCT04426422

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin group

all the patients were treated with metformin 1500-2000mg daily for 3 months.

Group Type EXPERIMENTAL

Metformin Hydrochloride

Intervention Type DRUG

treated with metformin 1500-2000mg daily

Interventions

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Metformin Hydrochloride

treated with metformin 1500-2000mg daily

Intervention Type DRUG

Other Intervention Names

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intervention group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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fengyi Yuan

Role: PRINCIPAL_INVESTIGATOR

Shenzhen People' hospital

Locations

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Shenzhen People' S Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GUTT2DM

Identifier Type: -

Identifier Source: org_study_id

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