A Phase 4 interventional study of Metformin in Type 1 Diabetes Mellitus and Metformin, sponsored by Shenzhen People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by Shenzhen People's Hospital · Phase 4, Interventional, and Treatment
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 .
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Shenzhen People's Hospital is the lead sponsor of 62 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
Also known as: metformin hydrochloride tablets
Change of hemoglobin A1c in percentage
analyze the change of hemoglobin A1c before and after the treatment
Time frame: 3 months
Change of weight in kilograms
analyze the change of weight in kilograms before and after the treatment
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
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Shenzhen People's Hospital