Back to resultsEffect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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.
Sites / Locations
- Shenzhen People' S Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
metformin group
Arm Description
all the patients were treated with metformin 1500-2000mg daily for 3 months.
Outcomes
Primary Outcome Measures
gut micribiota
the changes of gut micribiota
Secondary Outcome Measures
glycemic control
HbA1c
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426422
Brief Title
Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes
Official Title
Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
newly diagnosed type 2 diabetes was treated with metfomin for 3 months.
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin group
Arm Type
Experimental
Arm Description
all the patients were treated with metformin 1500-2000mg daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
Metformin Hydrochloride
Other Intervention Name(s)
intervention group
Intervention Description
treated with metformin 1500-2000mg daily
Primary Outcome Measure Information:
Title
gut micribiota
Description
the changes of gut micribiota
Time Frame
3 months
Secondary Outcome Measure Information:
Title
glycemic control
Description
HbA1c
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fengyi Yuan
Organizational Affiliation
Shenzhen People' hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen People' S Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no decided yet.
Learn more about this trial
Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes
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