Diabetes Mellitus, Type 1
Conditions
Brief summary
The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.
Interventions
DRUGMetformin
For arm 1, accept MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g tid) for 24 weeks.
DRUGInsulin
For arm 2, just accept insulin for 24 weeks
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 1 diabetes mellitus; 2. Age≥12 yr; 3. Tanner sexual maturation rating 2-5; 4. HbA1c levels: 7.5%-10%; 5. MDI or CSII ≥6 months; 6. Insulin dose ≥ 0.8U/kg before the enrollment，and the dosage is stable at least \>1 month（dosage change\<10%）.
Exclusion criteria
1. Serious acute and chronic complications associated with diabetes; 2. Repeated and serious hypoglycemia episodes repeatedly; 3. Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range); 4. Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR\<60ml/min/1.73m2); 5. Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III\ IV; 6. Female patients who have a sex life and are not willing to use contraceptive methods; 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | half one year |
Countries
China
Outcome results
None listed