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Effect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes

Sponsor
Shenzhen People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03590262
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
20.9
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Mar 31, 2019
Anticipated Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: metformin

patients take metformin 500mg twice or three times a day as add-on therapy to insulin for 3 months ,using self-control method.

Drug: Metformin
take the metformin 500mg twice or three times a day
Other Names:
  • metformin hydrochloride tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of hemoglobin A1c in percentage [3 months]

      analyze the change of hemoglobin A1c before and after the treatment

    Secondary Outcome Measures

    1. Change of weight in kilograms [3 months]

      analyze the change of weight in kilograms before and after the treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shenzhen People's Hospital Shenzhen Guangdong China 518020

    Sponsors and Collaborators

    • Shenzhen People's Hospital

    Investigators

    • Principal Investigator: Fengyi Yuan, associate chief physician

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03590262
    Other Study ID Numbers:
    • 723
    First Posted:
    Jul 18, 2018
    Last Update Posted:
    Jul 20, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Metformin

    Study Results

    No Results Posted as of Jul 20, 2018