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NCT05932251: ToPMedDiP

Towards Precision Medicine for Diabetes in Pregnancy

Suspended Last updated 19 August 2025
What this trial tests

trial testing Metformin in Gestational Diabetes in 103 participants. Suspended.

Timeline
19 June 2023
Primary endpoint
31 January 2025
30 September 2025

Quick facts

Lead sponsorZuyderland Medisch Centrum
StatusSuspended
Study typeOBSERVATIONAL
Enrollment103
Start date19 June 2023
Primary completion31 January 2025
Estimated completion30 September 2025
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Zuyderland Medisch Centrum — full company profile →

Who can join

Adults 18 to 45, female only, with Gestational Diabetes or Gestational Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Precision gestational diabetes treatment: a systematic review and meta-analyses.
    Benham JL, Gingras V, McLennan NM, Most J, et al · · 2023 · cited 25× · PMID 37794196 · DOI 10.1038/s43856-023-00371-0

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

Other recruiting trials for Gestational Diabetes

Currently open trials in the same condition.

Other Zuyderland Medisch Centrum trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05932251.

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