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Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

NCT03841591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-02-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Sinaa Hamdy, MBBCh · S Hamdy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-12-25
Completion
2019-01-15

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841591 on ClinicalTrials.gov