Status:
COMPLETED
Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes.
Lead Sponsor:
Tampere University Hospital
Collaborating Sponsors:
Turku University Hospital
Oulu University Hospital
Conditions:
Diabetic Pregnancy
Insulin Resistance
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The study investigates whether additional metformin medication in combination with regular insulin treatment will decrease the need of insulin for women with diabetes mellitus type 1 during pregnancy.
Detailed Description
Insulin resistance during pregnancy of diabetes mellitus type 1 patients (DM1) increases the need for insulin and makes it more difficult to maintain normoglycemia. Fetal exposure to hyperglycemia ind...
Eligibility Criteria
Inclusion
- a pregnancy of a woman with type 1 diabetes.
Exclusion
- multiple pregnancy, significant underlying disease (hearth disease, kidney transplant, IBD (inflammatory bowel disease ), SLE (systemic lupus erythematosus ), diseases with use of high dosage corticosteroids (severe asthma or rheumatic disease), severe complications of diabetes (nephropathy, neuropathy, gastroparesis or severe retinopathy), substance abuse, smoking, BMI \<18, strong early pregnancy nausea (=hyperemesis)
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03765359
Start Date
August 5 2019
End Date
December 19 2022
Last Update
June 7 2023
Active Locations (5)
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1
Helsinki University Hospital
Helsinki, Finland
2
Central Finland Health Care District
Jyväskylä, Finland
3
Oulu University hospital
Oulu, Finland
4
Tampere University Hospital
Tampere, Finland