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
  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.

Resource links provided by NLM:


Further study details as provided by K. Marcinkowski University of Medical Sciences:

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

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 ]

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681460

Contacts
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

Locations
Poland
Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences Recruiting
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
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, Globin Zinc
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014