NCT05932251

Towards Precision Medicine for Diabetes in Pregnancy

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 103 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Metformin	All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice

Timeline

• Start date: 2023-06-19
• Primary completion: 2025-01-31
• Completion: 2025-09-30
• First posted: 2023-07-06
• Last updated: 2025-08-19

Locations

1 site across 1 country: Netherlands