Metformin in Gestational Diabetes Mellitus | RxWiki

Metformin in Gestational Diabetes Mellitus

Overview[ - collapse ][ - ]

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	Diabetes, Gestational Insulin Resistance
Intervention	Drug: human recombined insulin Drug: metformin
Phase	N/A
Sponsor	K. Marcinkowski University of Medical Sciences
Responsible Party	K. Marcinkowski University of Medical Sciences
ClinicalTrials.gov Identifier	NCT00681460
First Received	May 19, 2008
Last Updated	August 10, 2009
Last verified	August 2009

Tracking Information[ + expand ][ + ]

First Received Date	May 19, 2008
Last Updated Date	August 10, 2009
Start Date	May 2008
Estimated Primary Completion Date	May 2011
Current Primary Outcome Measures	newborn weight [Time Frame: first hour of life] [Designated as safety issue: No]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	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.
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes, Gestational Insulin Resistance
Intervention	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
Study Arm (s)	Active Comparator: 1 gestational diabetes, insulin therapy Experimental: 2 gestational diabetes, metformin therapy No Intervention: 3 healthy controls, no treatment

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	180
Estimated Completion Date	May 2011
Estimated Primary Completion Date	March 2011
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)
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Hanna Mitkowska Wozniak, MD, PhD +48 601 88 60 00 hanna.mitkowska@onet.eu
Location Countries	Poland

Administrative Information[ + expand ][ + ]

NCT Number	NCT00681460
Other Study ID Numbers	KMUMS 705/07
Has Data Monitoring Committee	No
Information Provided By	K. Marcinkowski University of Medical Sciences
Study Sponsor	K. Marcinkowski University of Medical Sciences
Collaborators	Not Provided
Investigators	Study Chair: Jacek Brazert, MD.PhD.prof K Marcinkowski University of Med Sciences, Poznan, PolandStudy Director: Antoni J Duleba, MD.prof University of California at Davis, Sacramento, CA, USAPrincipal Investigator: Hanna Mitkowska Wozniak, MD.PhD K Marcinkowski University of Med Sciences, Poznan, Poland
Verification Date	August 2009

Locations[ + expand ][ + ]