Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy. The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin. Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
850-2550 mg every 24h.
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
Metformin benefits
Change of Weigth
Time frame: 50 weeks
Good glycemic control
Change of glycemic levels
Time frame: 50 weeks
Baby wellness
Weight
Time frame: Delivery
Adverse event profile
Number of adverse events
Time frame: 50 weeks
Fructosamine as a marker of insulinization
Concentration of fructosamine
Time frame: 50 weeks
Satisfaction with the treatment
Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best)
Time frame: 50 weeks
IL-6 profile
IL-6 levels
Time frame: 50 weeks
IL-10 profile and oxidativge stress as well as in lipid profile
IL-10 (ultrasensitive PCR) levels
Time frame: 50 weeks
Leptin profile
Leptin levels
Time frame: 50 weeks
Ladiponectin and oxidativge stress as well as in lipid profile
Ladiponectin levels
Time frame: 50 weeks
LPS profile
LPS levels
Time frame: 50 weeks
LBP profile and oxidativge stress as well as in lipid profile
LBP levels
Time frame: 50 weeks
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