ToPMedDiP: Towards Precision Medicine for Diabetes in Pregnancy

Sponsor

Zuyderland Medisch Centrum (Other)

Overall Status

Recruiting

CT.gov ID

NCT05932251

Collaborator

(none)

103

Enrollment

Location

30.4

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Gestational Diabetes Mellitus	Drug: Metformin

Study Design

Study Type:

Observational

Anticipated Enrollment :

103 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Towards Precision Medicine for Diabetes in Pregnancy

Actual Study Start Date :

Jun 19, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Low insulin sensitivity Women will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort	Drug: Metformin All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice
Low insulin secretion Women will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort	Drug: Metformin All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice

Arm

Intervention/Treatment

Low insulin sensitivity

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

Drug: Metformin

All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice

Low insulin secretion

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

Drug: Metformin

All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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