Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Study Overview
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Brief Summary
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Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy. This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.

Official Title
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Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin: A Randomized Controlled Trial

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: Insulin
* Drug: Metformin
* Other: Assessment of weight gain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged (19-35) years BMI 18-30 kg/m2 Gestational age >24 weeks Singleton pregnancy Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG > 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone. Exclusion Criteria: Pregnant women with preexisting diabetes mellitus Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis). Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc). Fetal anomalies identified on ultrasound prior to initiation of therapy. Patients who refused to participate

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin Group<br>This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin. | Drug: Insulin<br>* Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.<br>Other: Assessment of weight gain<br>* Body weight will be measured monthly from the start of treatment till delivery.<br>|
| Active Comparator: Metformin Group<br>This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal. | Drug: Metformin<br>* Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.<br>* Other names: Cidophage;Other: Assessment of weight gain<br>* Body weight will be measured monthly from the start of treatment till delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of maternal weight gain per week | Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-min APGAR score | APGAR score at minute 1 after delivery | 1 minute | 
| 5-min APGAR score | APGAR score at minute 5 after delivery | 5 minutes | 
| Incidence of neonatal hypoglycemia | Number of neonates with two or more neonatal glucose value <2.6 mmol per liter during the first day after delivery. | 1 day | 
| Incidence of neonatal respiratory distress | Number of neonates needing at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery. | 1 day | 
| Incidence of macrosomia | Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age | 1 hour |