Clinical trial NCT00681460: Metformin in Gestational Diabetes Mellitus
Official title: Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Insulin Resistance
Keywords: gestational diabetes
birth weight
fetal growth
insulin resistance
oxidative stress
inflammatory reaction
Fetal Development
Lead sponsor: K. Marcinkowski University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: newborn weight
timeFrame: first hour of life
Secondary outcomes:
measure: parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,
timeFrame: during pregnancy and up to twelve hours after delivery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences
Study officials:
affiliation: K Marcinkowski University of Med Sciences, Poznan, Poland
name: Jacek Brazert, MD.PhD.prof
role: STUDY_CHAIR
affiliation: University of California at Davis, Sacramento, CA, USA
name: Antoni J Duleba, MD.prof
role: STUDY_DIRECTOR
References: