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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 19, 2008

Last Updated Date

August 10, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

newborn weight [ Time Frame: first hour of life ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00681460 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Metformin in Gestational Diabetes Mellitus

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes, Gestational
Insulin Resistance

Intervention ^ICMJE

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

Intervention: Drug: human recombined insulin
Experimental: 2
gestational diabetes, metformin therapy

Intervention: Drug: metformin
No Intervention: 3
healthy controls, no treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

May 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00681460

Other Study ID Numbers ^ICMJE

KMUMS 705/07

Has Data Monitoring Committee

Responsible Party

Div.of Obstet.&Womens Disease Dep. of Obstet.&Gyn., Hanna Mitkowska Wozniak, K. Marcinkowski University of Medical Sciences

Study Sponsor ^ICMJE

K. Marcinkowski University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

K. Marcinkowski University of Medical Sciences

Verification Date

August 2009

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

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