Skip to main content
OpenTrials
Completed

NCT Number: NCT00681460

Metformin in Gestational Diabetes Mellitus

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Poznan, 60-535, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

human recombined insulin

Drug

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

metformin

Drug

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

Primary outcomes

  1. newborn weight

    Time frame: first hour of life

Secondary outcomes

  1. parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,

    Time frame: during pregnancy and up to twelve hours after delivery

Sponsors and collaborators

Lead sponsor

K. Marcinkowski University of Medical Sciences

Other

Registry information

Official study title

Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.

Acronym: MetGDM

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 21, 2008
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.