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

Southern University of Science and Technology

Status and phase: Unknown; Phase 4

Conditions: Metformin; Type 1 Diabetes Mellitus

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03590262

723

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin