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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SUSPENDED
103 participants
OBSERVATIONAL
2023-06-19
2025-09-30
Brief Summary
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Study population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin.
Main study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Low insulin sensitivity
Women will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort
Metformin
All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice
Low insulin secretion
Women will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort
Metformin
All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice
Interventions
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Metformin
All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice
Eligibility Criteria
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Inclusion Criteria
* assigned to pharmacological (ie metformin) treatment for GDM.
Exclusion Criteria
* using medication related to study outcomes prior to GDM diagnosis (insulin, metformin, glyburide, systemic steroids, mood stabilizers, ADHD medication)
* smoking or using recreational drugs that may affect pregnancy outcomes
18 Years
45 Years
FEMALE
No
Sponsors
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Zuyderland Medisch Centrum
OTHER
Responsible Party
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Principal Investigators
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Jasper Most, PhD
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medisch Centrum
Jonas Ellerbrock, MD, PhDc
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medisch Centrum
Locations
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Zuyderland Medisch Centrum
Heerlen, , Netherlands
Countries
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Other Identifiers
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NL80773.096.22
Identifier Type: -
Identifier Source: org_study_id
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