Back to resultsEffect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus, Metformin
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；
Exclusion Criteria:
pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs
Sites / Locations
- Shenzhen People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
metformin
Arm Description
patients take metformin 500mg twice or three times a day as add-on therapy to insulin for 3 months ,using self-control method.
Outcomes
Primary Outcome Measures
Change of hemoglobin A1c in percentage
analyze the change of hemoglobin A1c before and after the treatment
Secondary Outcome Measures
Change of weight in kilograms
analyze the change of weight in kilograms before and after the treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03590262
Brief Title
Effect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes
Official Title
Effect of Metformin as add-on Therapy on Glycemic Control and Other Diabetes-Related Outcomes in Type 1 Diabetic Patients:a Open-label,Self-control Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
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
Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of metformin as add-on therapy on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.
Detailed Description
Design An open-label, add-on, self-control clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 20 participants with type 1 diabetes, aged 18-60 years, will be recruited and treated with metformin as add-on therapy with insulin for 12 weeks.
Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Experimental
Arm Description
patients take metformin 500mg twice or three times a day as add-on therapy to insulin for 3 months ,using self-control method.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
metformin hydrochloride tablets
Intervention Description
take the metformin 500mg twice or three times a day
Primary Outcome Measure Information:
Title
Change of hemoglobin A1c in percentage
Description
analyze the change of hemoglobin A1c before and after the treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of weight in kilograms
Description
analyze the change of weight in kilograms before and after the treatment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；
Exclusion Criteria:
pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuzhen Zhang
Phone
86-13714902238
Email
876538754@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Xu
Phone
86-13692156916
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengyi Yuan
Organizational Affiliation
associate chief physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuzhen Zhang, MD
Phone
0086-755-22943422
Email
876538754@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes
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