Effect of Metformin on Gut Microbiota Changes and Glycemi... | NCT04426422

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

NCT04426422

Sponsor

Shenzhen People's Hospital

Status

Completed

Last Update Posted

Jun 11, 2020Actual

Enrollment

52Actual

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Metformin Hydrochloride

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

Jun 7, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metformin group	Experimental	all the patients were treated with metformin 1500-2000mg daily for 3 months.	Drug: Metformin Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin Hydrochloride	Drug	treated with metformin 1500-2000mg daily	metformin group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
glycemic control	HbA1c	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
fengyi Yuan	Shenzhen People' hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shenzhen People' S Hospital		Shenzhen	Guangdong	518000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

no decided yet.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided