Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841591
• Other study ID #: MatWt-GDM
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: February 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 15, 2019
• Est. primary completion date: December 25, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Weight Gain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-min APGAR score	APGAR score at minute 1 after delivery	1 minute
Secondary	5-min APGAR score	APGAR score at minute 5 after delivery	5 minutes
Secondary	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
Secondary	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
Secondary	Incidence of macrosomia	Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age	1 hour