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

Phase 4

• Conditions: Type 1 Diabetes Mellitus; Metformin
• Interventions: Drug: Metformin

• Registration Number: NCT03590262
• Lead Sponsor: Shenzhen People's Hospital

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 .

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-05
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-18
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-20
• Primary Completion: 2019-03-31
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；

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Exclusion Criteria

pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of hemoglobin A1c in percentage	3 months	analyze the change of hemoglobin A1c before and after the treatment

Secondary Outcome Measures

Name	Time	Method
Change of weight in kilograms	3 months	analyze the change of weight in kilograms before and after the treatment

Trial Locations

Locations (1)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China