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Metformin in Gestational Diabetes Mellitus

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00681460
Acronym
MetGDM
Enrollment
78
Registered
2008-05-21
Start date
2008-05-31
Completion date
2013-05-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational, Insulin Resistance

Keywords

gestational diabetes, birth weight, fetal growth, insulin resistance, oxidative stress, inflammatory reaction, Fetal Development

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.

Interventions

DRUGhuman recombined insulin

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

DRUGmetformin

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

Sponsors

K. Marcinkowski University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
newborn weightfirst hour of life

Secondary

MeasureTime frame
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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026