Towards Precision Medicine for Diabetes in Pregnancy

Recruiting

• Conditions: Gestational Diabetes; Gestational Diabetes Mellitus
• Interventions: Drug: Metformin

• Registration Number: NCT05932251
• Lead Sponsor: Zuyderland Medisch Centrum

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-19
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low insulin sensitivity	Metformin	Women will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort
Low insulin secretion	Metformin	Women will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort

Primary Outcome Measures

Name	Time	Method
glucose-disposition-index	35-37 weeks gestation	glucose-disposition-index is calculated as product of Stumvoll- and Matsuda-index, assessed during a 75g-oral glucose tolerance test,

Secondary Outcome Measures

Name	Time	Method
Dietary intake	24-28 and 35-37 weeks gestation	Average energy intake, measured over 7 days using online dietary records
Glucose control	24-28 and 35-37 weeks gestation	Time in range (3-10 mol/l), measured over 7 days using continuous glucose monitors
Delivery complications	Birth	occurence and type of complications during delivery
Neonatal body weight	at birth, and at 6 weeks of age	Neonatal body weight
Neonatal body length	at birth, and at 6 weeks of age	Neonatal body length
Insulin treatment	35-37 weeks gestation	requirement for additional insulin treatment
HbA1c	24-28 and 35-37 weeks gestation	HbA1c concentration
Body weight	24-28 and 35-37 weeks gestation	Fasting body weight, kg
Body fat mass	24-28 and 35-37 weeks gestation	Fasting body fat mass, in kg
Physical Activity	24-28 and 35-37 weeks gestation	Average steps per day, measured over 7-day period using accelerometry

Trial Locations

Locations (1)

Zuyderland Medisch Centrum; 🇳🇱 Heerlen, Netherlands