Metformin in Gestational Diabetes Mellitus (MetGDM)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes, Gestational Insulin Resistance |
Drug: human recombined insulin Drug: metformin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial. |
- newborn weight [ Time Frame: first hour of life ] [ Designated as safety issue: No ]
- 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 ]
| 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 |
|---|---|
|
Active Comparator: 1
gestational diabetes, insulin therapy
|
Drug: human recombined insulin
multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status
|
|
Experimental: 2
gestational diabetes, metformin therapy
|
Drug: metformin
pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg
|
|
No Intervention: 3
healthy controls, no treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts 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)
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Div.of Obstet.&Womens Disease Dep. of Obstet.&Gyn., Hanna Mitkowska Wozniak, K. Marcinkowski University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00681460 History of Changes |
| Other Study ID Numbers: | KMUMS 705/07 |
| Study First Received: | May 19, 2008 |
| Last Updated: | August 10, 2009 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by K. Marcinkowski University of Medical Sciences:
|
gestational diabetes birth weight fetal growth insulin resistance |
oxidative stress inflammatory reaction Fetal Development |
Additional relevant MeSH terms:
|
Diabetes Mellitus Insulin Resistance Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism |
Pregnancy Complications Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013