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Metformin in Gestational Diabetes Mellitus (MetGDM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by K. Marcinkowski University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
K. Marcinkowski University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00681460
First received: May 19, 2008
Last updated: August 10, 2009
Last verified: August 2009

May 19, 2008
August 10, 2009
May 2008
March 2011   (final data collection date for primary outcome measure)
newborn weight [ Time Frame: first hour of life ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681460 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes, Gestational
  • Insulin Resistance
  • Drug: human recombined insulin
    multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status
  • Drug: metformin
    pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg
  • Active Comparator: 1
    gestational diabetes, insulin therapy
    Intervention: Drug: human recombined insulin
  • Experimental: 2
    gestational diabetes, metformin therapy
    Intervention: Drug: metformin
  • No Intervention: 3
    healthy controls, no treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
May 2011
March 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
Yes
Contact: Hanna Mitkowska Wozniak, MD, PhD +48 601 88 60 00 hanna.mitkowska@onet.eu
Contact: Agnieszka Zawiejska, MD, PhD +48 600 22 33 06 agazaw@poczta.onet.pl
Poland
 
NCT00681460
KMUMS 705/07
No
Div.of Obstet.&Womens Disease Dep. of Obstet.&Gyn., Hanna Mitkowska Wozniak, K. Marcinkowski University of Medical Sciences
K. Marcinkowski University of Medical Sciences
Not Provided
Study Chair: Jacek Brazert, MD.PhD.prof K Marcinkowski University of Med Sciences, Poznan, Poland
Study Director: Antoni J Duleba, MD.prof University of California at Davis, Sacramento, CA, USA
Principal Investigator: Hanna Mitkowska Wozniak, MD.PhD K Marcinkowski University of Med Sciences, Poznan, Poland
K. Marcinkowski University of Medical Sciences
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP