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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | 850-2550 mg every 24h. |
|
| Insulin Detemir | Active Comparator | Individual doses according to glycemic controls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 850-2550 mg every 24h. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Metformin benefits | Change of Weigth | 50 weeks |
| Good glycemic control | Change of glycemic levels | 50 weeks |
| Baby wellness | Weight | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event profile | Number of adverse events | 50 weeks |
| Fructosamine as a marker of insulinization | Concentration of fructosamine |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011644 | Puerperal Disorders |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 |
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Inferiority, randomized, open, parallel arms, multicenter clinical trial
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| Insulin Detemir |
| Drug |
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls. |
|
| 50 weeks |
| Satisfaction with the treatment | Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best) | 50 weeks |
| IL-6 profile | IL-6 levels | 50 weeks |
| IL-10 profile and oxidativge stress as well as in lipid profile | IL-10 (ultrasensitive PCR) levels | 50 weeks |
| Leptin profile | Leptin levels | 50 weeks |
| Ladiponectin and oxidativge stress as well as in lipid profile | Ladiponectin levels | 50 weeks |
| LPS profile | LPS levels | 50 weeks |
| LBP profile and oxidativge stress as well as in lipid profile | LBP levels | 50 weeks |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |