Metformin in Gestational Diabetes Mellitus (MetGDM)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diabetes, Gestational; Insulin Resistance	Drug: human recombined insulin; Drug: metformin	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	78 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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.
Study Start Date :	May 2008
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. newborn weight [ Time Frame: first hour of life ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Poland
Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences
Poznan, Poland, 60-535

Sponsors and Collaborators

K. Marcinkowski University of Medical Sciences

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Agnieszka Zawiejska, MD, PhD, Department of Obstetrics and Women's Diseases, Senior Lecturer, K. Marcinkowski University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00681460 History of Changes
Other Study ID Numbers:	KMUMS 705/07
First Posted:	May 21, 2008
Last Update Posted:	May 27, 2015
Last Verified:	May 2015

Keywords provided by Agnieszka Zawiejska, MD, PhD, 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, Gestational; Diabetes Mellitus; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism	Pregnancy Complications; Insulin, Globin Zinc; Insulin; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs