Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Phase 3

Completed

• Conditions: Gestational Diabetes
• Interventions: Drug: Insulin; Drug: Metformin; Other: Assessment of weight gain

• Registration Number: NCT03841591
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-12-25
• Study Completion: 2019-01-15
• Status Verified: 2019-02
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Group	Insulin	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.
Insulin Group	Assessment of weight gain	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.
Metformin Group	Assessment of weight gain	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.
Metformin Group	Metformin	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.

Primary Outcome Measures

Name	Time	Method
Rate of maternal weight gain per week	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of neonatal respiratory distress	1 day	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.
5-min APGAR score	5 minutes	APGAR score at minute 5 after delivery
Incidence of neonatal hypoglycemia	1 day	Number of neonates with two or more neonatal glucose value \<2.6 mmol per liter during the first day after delivery.
1-min APGAR score	1 minute	APGAR score at minute 1 after delivery
Incidence of macrosomia	1 hour	Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age

Trial Locations

Locations (1)

Ain SHams Maternity Hospital; 🇪🇬 Cairo, Abbaseya, Egypt