Diabetes, Gestational, Perinatal Disorder, Puerperal Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMetformin
850-2550 mg every 24h.
DRUGInsulin Detemir
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Inferiority, randomized, open, parallel arms, multicenter clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. 18-45 years old. 2. Diagnosis of GD, with fasting glucose \<120 mg / dL. 3. not controlled by diet: fasting capillary blood glucose\> 95 mg / dl in at least 2-3 times or 1 hour postprandial \>140 mg / dl on, at least 2-3 times a week. 4. 2nd or 3rd trimesters of pregnancy. 5. Able to give informed consent.
Exclusion criteria
1. Psychopathological situations that do not guarantee proper adhesion to follow up 2. 1st trimester of pregnancy 3. gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin. 4. Patients who can not attend the scheduled consultation. 5. Language barrier limiting for understanding treatment settings 6. Twin pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metformin benefits | 50 weeks | Change of Weigth |
| Good glycemic control | 50 weeks | Change of glycemic levels |
| Baby wellness | Delivery | Weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 profile | 50 weeks | IL-6 levels |
| IL-10 profile and oxidativge stress as well as in lipid profile | 50 weeks | IL-10 (ultrasensitive PCR) levels |
| Leptin profile | 50 weeks | Leptin levels |
| Fructosamine as a marker of insulinization | 50 weeks | Concentration of fructosamine |
| LPS profile | 50 weeks | LPS levels |
| LBP profile and oxidativge stress as well as in lipid profile | 50 weeks | LBP levels |
| Ladiponectin and oxidativge stress as well as in lipid profile | 50 weeks | Ladiponectin levels |
| Adverse event profile | 50 weeks | Number of adverse events |
| Satisfaction with the treatment | 50 weeks | Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best) |
Outcome results
None listed