Metformin in Gestational Diabetes Mellitus

Insulin Resistance Clinical Trial

— MetGDM  

Official title:

Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681460
• Other study ID #: KMUMS 705/07
• Status: Completed
• Phase: N/A
• First received: May 19, 2008
• Last updated: May 23, 2015
• Start date: May 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: K. Marcinkowski University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• 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
• metformin
pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg

Locations

Country	Name	City	State
Poland	Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
K. Marcinkowski University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	newborn weight		first hour of life	No
Secondary	parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,		during pregnancy and up to twelve hours after delivery	No