Metformin in Gestational Diabetes Mellitus (MetGDM)
Primary Purpose
Diabetes, Gestational, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
human recombined insulin
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes, Gestational focused on measuring gestational diabetes, birth weight, fetal growth, insulin resistance, oxidative stress, inflammatory reaction, Fetal Development
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)
Sites / Locations
- Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
gestational diabetes, insulin therapy
gestational diabetes, metformin therapy
Outcomes
Primary Outcome Measures
newborn weight
Secondary Outcome Measures
parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,
Full Information
NCT ID
NCT00681460
First Posted
May 19, 2008
Last Updated
May 23, 2015
Sponsor
K. Marcinkowski University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00681460
Brief Title
Metformin in Gestational Diabetes Mellitus
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
K. Marcinkowski University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational, Insulin Resistance
Keywords
gestational diabetes, birth weight, fetal growth, insulin resistance, oxidative stress, inflammatory reaction, Fetal Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
gestational diabetes, insulin therapy
Arm Title
2
Arm Type
Experimental
Arm Description
gestational diabetes, metformin therapy
Intervention Type
Drug
Intervention Name(s)
human recombined insulin
Intervention Description
multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg
Primary Outcome Measure Information:
Title
newborn weight
Time Frame
first hour of life
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Brazert, MD.PhD.prof
Organizational Affiliation
K Marcinkowski University of Med Sciences, Poznan, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antoni J Duleba, MD.prof
Organizational Affiliation
University of California at Davis, Sacramento, CA, USA
Official's Role
Study Director
Facility Information:
Facility Name
Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
12. IPD Sharing Statement
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Metformin in Gestational Diabetes Mellitus
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