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Sponsored by: |
K. Marcinkowski University of Medical Sciences |
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Information provided by: | K. Marcinkowski University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00681460 |
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 our study, we 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.
Condition | Intervention |
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Diabetes, Gestational Insulin Resistance |
Drug: human recombined insulin Drug: metformin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial. |
Estimated Enrollment: | 180 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
gestational diabetes, insulin therapy
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Drug: human recombined insulin
multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status
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2: Experimental
gestational diabetes, metformin therapy
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Drug: metformin
pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg
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3: No Intervention
healthy controls, no treatment
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences | Recruiting |
Poznan, Poland, 60-535 |
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 |
Responsible Party: | K. Marcinkowski University of Medical Sciences ( Div.of Obstet.&Womens Disease Dep. of Obstet.&Gyn., Hanna Mitkowska Wozniak ) |
Study ID Numbers: | KMUMS 705/07 |
Study First Received: | May 19, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00681460 |
Health Authority: | Poland: Ministry of Health |
gestational diabetes birth weight fetal growth insulin resistance |
oxidative stress inflammatory reaction Fetal Development |
Birth Weight Metabolic Diseases Pregnancy Complications Metformin Diabetes Mellitus Stress Endocrine System Diseases Diabetes, Gestational |
Insulin Inflammation Body Weight Hyperinsulinism Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic disorder |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |