Metformin in Gestational Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes, Gestational; Insulin Resistance
• Interventions: Drug: human recombined insulin; Drug: metformin

• Registration Number: NCT00681460
• Lead Sponsor: K. Marcinkowski University of Medical Sciences

Brief Summary

Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child.

In the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-23
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

• diabetes diagnosed during pregnancy
• single pregnancy
• ineffective diet therapy

Exclusion Criteria

• pregestational diabetes
• fetal malformation
• multiple pregnancy
• contraindications to metformin therapy (liver or kidney disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	human recombined insulin	gestational diabetes, insulin therapy
2	metformin	gestational diabetes, metformin therapy

Primary Outcome Measures

Name	Time	Method
newborn weight	first hour of life

Secondary Outcome Measures

Name	Time	Method
parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,	during pregnancy and up to twelve hours after delivery

Trial Locations

Locations (1)

Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences; 🇵🇱 Poznan, Poland