Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05932251
Status:
SUSPENDED
Last Update Posted:
2025-08-19
First Post:
2023-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Towards Precision Medicine for Diabetes in Pregnancy
Sponsor:
Zuyderland Medisch Centrum
Organization:
Study Overview
Official Title:
Towards Precision Medicine for Diabetes in Pregnancy
Status:
SUSPENDED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ToPMedDiP
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: