NCT03841591

Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 19 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	Insulin	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.
DRUG	Metformin	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.
OTHER	Assessment of weight gain	Body weight will be measured monthly from the start of treatment till delivery.

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-12-25
• Completion: 2019-01-15
• First posted: 2019-02-15
• Last updated: 2019-02-15

Locations

1 site across 1 country: Egypt