Towards Precision Medicine for Diabetes in Pregnancy (ToPMedDiP)

Zuyderland Medisch Centrum

Status: Suspended

Conditions: Gestational Diabetes; Gestational Diabetes Mellitus

Treatments: Drug: Metformin

Study type: Observational

Funder types: Other

Identifiers

NCT05932251

NL80773.096.22

Details and patient eligibility

About

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.

Enrollment: 103 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

103 participants in 2 patient groups

Low insulin sensitivity

Description:

Women will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort

Treatment:

Drug: Metformin

Low insulin secretion

Description:

Women will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort

Treatment:

Drug: Metformin