Towards Precision Medicine for Diabetes in Pregnancy
Key facts
- Who runs it
- Zuyderland Medisch Centrum
- Where
- Netherlands1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Suspended
- People taking part
- 103 people, planned
- Started
- 19 Jun 2023
- Ended
- 30 Sept 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Metformin
- Record updated
- 19 August 2025
- Why it stopped
- Poor recruitment efficacy
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- having a confirmed single, viable pregnancy past 20 weeks gestation
- assigned to pharmacological (ie metformin) treatment for GDM
Who cannot take part
- 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
- pre-existing diabetes, hypertension (SBP >160 mmHg \& DBP >110 mmHg)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion.
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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.
The 2 groups in the trial
- 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
Treatment: Metformin
- 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
Treatment: Metformin
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 19 August 2025