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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Experimental | patients take metformin 500mg twice or three times a day as add-on therapy to insulin for 3 months ,using self-control method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | take the metformin 500mg twice or three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of hemoglobin A1c in percentage | analyze the change of hemoglobin A1c before and after the treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of weight in kilograms | analyze the change of weight in kilograms before and after the treatment | 3 months |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuzhen Zhang | Contact | 86-13714902238 | 876538754@qq.com | |
| Ping Xu | Contact | 86-13692156916 |
| Name | Affiliation | Role |
|---|---|---|
| Fengyi Yuan | associate chief physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | 518020 | China |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |