Metformin in Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child. In the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation.

Official Title
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Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.

Conditions
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Diabetes, Gestational, Insulin Resistance

Intervention / Treatment
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* Drug: human recombined insulin
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetes diagnosed during pregnancy single pregnancy ineffective diet therapy Exclusion Criteria: pregestational diabetes fetal malformation multiple pregnancy contraindications to metformin therapy (liver or kidney disease)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>gestational diabetes, insulin therapy | Drug: human recombined insulin<br>* multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status<br>|
| Experimental: 2<br>gestational diabetes, metformin therapy | Drug: metformin<br>* pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| newborn weight |  | first hour of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth, |  | during pregnancy and up to twelve hours after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, birth weight, fetal growth, insulin resistance, oxidative stress, inflammatory reaction, Fetal Development