Clinical trial NCT05932251: Towards Precision Medicine for Diabetes in Pregnancy
Official title: Towards Precision Medicine for Diabetes in Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Gestational Diabetes Mellitus
Keywords: insulin sensitivity
insulin secretion
continuous glucose monitoring
metformin
physical activity
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, who are screened (selection per EXPECT-calculator risk for GDM \>3.5% \[26\]) and diagnosed with GDM and treated with metformin are eligible. Per current clinical practice (IADPSG/WHO2013), GDM will be diagnosed at 24-28 weeks by a 75g-oral glucose-tolerance-test (OGTT), if plasma glucose concentrations are: fasting \>5.1 mmol/L; 1-h \>10 mmol/L; or 2-h \>8.5 mmol/L.\[2, 25\] Metformin-treatment is initiated, if plasma glucose concentrations during the OGTT are: fasting \>5.3 mmol/L; and postprandial: \>7.8 mmol/L.

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.


Eligibility criteria: 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

Primary outcomes:
measure: glucose-disposition-index
timeFrame: 35-37 weeks gestation
Secondary outcomes:
measure: Insulin treatment
timeFrame: 35-37 weeks gestation
measure: HbA1c
timeFrame: 24-28 and 35-37 weeks gestation
measure: Body weight
timeFrame: 24-28 and 35-37 weeks gestation
measure: Body fat mass
timeFrame: 24-28 and 35-37 weeks gestation
measure: Physical Activity
timeFrame: 24-28 and 35-37 weeks gestation
measure: Dietary intake
timeFrame: 24-28 and 35-37 weeks gestation
measure: Glucose control
timeFrame: 24-28 and 35-37 weeks gestation
measure: Delivery complications
timeFrame: Birth
measure: Neonatal body weight
timeFrame: at birth, and at 6 weeks of age
measure: Neonatal body length
timeFrame: at birth, and at 6 weeks of age
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
Study officials:
affiliation: Zuyderland Medisch Centrum
name: Jasper Most, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zuyderland Medisch Centrum
name: Jonas Ellerbrock, MD, PhDc
role: PRINCIPAL_INVESTIGATOR
References: