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 Type
OBSERVATIONAL
Enrollment
103
All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice
Zuyderland Medisch Centrum
Heerlen, Netherlands
glucose-disposition-index
glucose-disposition-index is calculated as product of Stumvoll- and Matsuda-index, assessed during a 75g-oral glucose tolerance test,
Time frame: 35-37 weeks gestation
Insulin treatment
requirement for additional insulin treatment
Time frame: 35-37 weeks gestation
HbA1c
HbA1c concentration
Time frame: 24-28 and 35-37 weeks gestation
Body weight
Fasting body weight, kg
Time frame: 24-28 and 35-37 weeks gestation
Body fat mass
Fasting body fat mass, in kg
Time frame: 24-28 and 35-37 weeks gestation
Physical Activity
Average steps per day, measured over 7-day period using accelerometry
Time frame: 24-28 and 35-37 weeks gestation
Dietary intake
Average energy intake, measured over 7 days using online dietary records
Time frame: 24-28 and 35-37 weeks gestation
Glucose control
Time in range (3-10 mol/l), measured over 7 days using continuous glucose monitors
Time frame: 24-28 and 35-37 weeks gestation
Delivery complications
occurence and type of complications during delivery
Time frame: Birth
Neonatal body weight
Neonatal body weight
Time frame: at birth, and at 6 weeks of age
Neonatal body length
Neonatal body length
Time frame: at birth, and at 6 weeks of age
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