MeDiGes Study: Metformine Use in Gestational Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy

Conditions
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Diabetes, Gestational, Perinatal Disorder, Puerperal Disorder

Intervention / Treatment
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* Drug: Metformin
* Drug: Insulin Detemir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years old. Diagnosis of GD, with fasting glucose <120 mg / dL. 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. 2nd or 3rd trimesters of pregnancy. Able to give informed consent. Exclusion Criteria: Psychopathological situations that do not guarantee proper adhesion to follow up 1st trimester of pregnancy gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin. Patients who can not attend the scheduled consultation. Language barrier limiting for understanding treatment settings Twin pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Inferiority, randomized, open, parallel arms, multicenter clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>850-2550 mg every 24h. | Drug: Metformin<br>* 850-2550 mg every 24h.<br>Drug: Insulin Detemir<br>* Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.<br>|
| Active Comparator: Insulin Detemir<br>Individual doses according to glycemic controls. | Drug: Metformin<br>* 850-2550 mg every 24h.<br>Drug: Insulin Detemir<br>* Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin benefits | Change of Weigth | 50 weeks | 
| Good glycemic control | Change of glycemic levels | 50 weeks | 
| Baby wellness | Weight | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile | Number of adverse events | 50 weeks | 
| Fructosamine as a marker of insulinization | Concentration of fructosamine | 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 |