Understanding diabetes treatment in pregnant women
Towards Precision Medicine for Diabetes in Pregnancy
Zuyderland Medisch Centrum · NCT05932251
This study is testing how well metformin works for pregnant women with gestational diabetes, especially looking at those who have insulin resistance compared to those with low insulin levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 103 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Zuyderland Medisch Centrum (other) |
| Locations | 1 site (Heerlen) |
| Trial ID | NCT05932251 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of metformin in treating gestational diabetes mellitus (GDM) by comparing treatment outcomes between patients with different metabolic profiles. It focuses on women diagnosed with GDM, specifically those experiencing insulin resistance versus those with low insulin secretion. The study will track various parameters, including glucose levels, insulin sensitivity, and weight gain, to better tailor treatment approaches for pregnant women with GDM. A total of 103 participants will be monitored during late pregnancy to assess the need for additional insulin treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women diagnosed with gestational diabetes mellitus who are being treated with metformin.
Not a fit: Patients with pre-existing diabetes or those on medications that affect study outcomes prior to their GDM diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for managing gestational diabetes, improving outcomes for both mothers and babies.
How similar studies have performed: While there have been studies on gestational diabetes treatment, this approach focusing on distinct metabolic phenotypes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * having a confirmed single, viable pregnancy past 20 weeks gestation. * assigned to pharmacological (ie metformin) treatment for GDM. Exclusion Criteria: * pre-existing diabetes, hypertension (SBP \>160 mmHg \& DBP \>110 mmHg) * 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
Where this trial is running
Heerlen
- Zuyderland Medisch Centrum — Heerlen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Jasper Most, PhD — Zuyderland Medisch Centrum
- Study coordinator: Jasper Most, PhD
- Email: j.most@zuyderland.nl
- Phone: 0031625159747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes, Gestational Diabetes Mellitus, insulin sensitivity, insulin secretion, continuous glucose monitoring, metformin, physical activity