Metformin to Treat Corticosteroids-induced Hyperglycemia
NCT ID: NCT04332393
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
187 participants
INTERVENTIONAL
2020-07-05
2025-05-05
Brief Summary
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Although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates.
In the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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metformin group
Metformin
Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 1700 mg around 22:00. Modifications may take place according to glycemic control
No treatment group
No interventions assigned to this group
Interventions
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Metformin
Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 1700 mg around 22:00. Modifications may take place according to glycemic control
Eligibility Criteria
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Inclusion Criteria
* Before or within 24 hours following the first dose of betamethasone
* ≥18 years old
Exclusion Criteria
* Known allergic sensitivity to metformin
* Known chronic heart failure
* Known chronic renal failure
* Refuse to participate
* Refuse to perform glucose challenge test/glucose tolerance test later on
18 Years
FEMALE
No
Sponsors
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The Baruch Padeh Medical Center, Poriya
OTHER_GOV
Responsible Party
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Locations
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Baruch Padeh Medical center, Poriya
Tiberias, North, Israel
Emek medical center
Afula, , Israel
Galilee medical center
Nahariya, , Israel
Ziv medical center
Safed, , Israel
Countries
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Other Identifiers
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21-20POR
Identifier Type: -
Identifier Source: org_study_id
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