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Towards Precision Medicine for Diabetes in Pregnancy

NCT05932251 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 103

Last updated 2025-08-19

No results posted yet for this study

Summary

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.

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.

Conditions

  • Gestational Diabetes
  • Gestational Diabetes Mellitus

Interventions

DRUG

Metformin

All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Principal Investigators

  • Jasper Most, PhD · Zuyderland Medisch Centrum

  • Jonas Ellerbrock, MD, PhDc · Zuyderland Medisch Centrum

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-19
Primary Completion
2025-01-31
Completion
2025-09-30

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05932251 on ClinicalTrials.gov