Metformin in Gestational Diabetes Mellitus

NCT ID: NCT00681460

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-05-31

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.

Conditions

Diabetes, Gestational; Insulin Resistance

Study Design

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

Study Groups

1

gestational diabetes, insulin therapy

Group Type: ACTIVE_COMPARATOR

human recombined insulin

Intervention Type: DRUG

multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status

2

gestational diabetes, metformin therapy

Group Type: EXPERIMENTAL

metformin

Intervention Type: DRUG

pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg

Interventions

human recombined insulin

multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status

Intervention Type: DRUG

metformin

pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

K. Marcinkowski University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Agnieszka Zawiejska, MD, PhD

Department of Obstetrics and Women's Diseases, Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacek Brazert, MD.PhD.prof

Role: STUDY_CHAIR

K Marcinkowski University of Med Sciences, Poznan, Poland

Antoni J Duleba, MD.prof

Role: STUDY_DIRECTOR

University of California at Davis, Sacramento, CA, USA

Locations

Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences

Poznan, , Poland

Countries

Poland

Other Identifiers

KMUMS 705/07

Identifier Type: -

Identifier Source: org_study_id