Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

NCT ID: NCT03841591

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-01-15

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Insulin Group

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.

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

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.

Assessment of weight gain

Intervention Type: OTHER

Body weight will be measured monthly from the start of treatment till delivery.

Metformin Group

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.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

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.

Assessment of weight gain

Intervention Type: OTHER

Body weight will be measured monthly from the start of treatment till delivery.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Assessment of weight gain

Body weight will be measured monthly from the start of treatment till delivery.

Intervention Type: OTHER

Other Intervention Names

Cidophage

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sinaa Hamdy Abo ElWafa

Resident of O&G

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sinaa Hamdy, MBBCh

Role: PRINCIPAL_INVESTIGATOR

S Hamdy

Locations

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Countries

Egypt

Other Identifiers

MatWt-GDM

Identifier Type: -

Identifier Source: org_study_id