Gestational Diabetes, Gestational Diabetes Mellitus
Conditions
Keywords
insulin sensitivity, insulin secretion, continuous glucose monitoring, metformin, physical activity
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.
Interventions
DRUGMetformin
All patients are diagnosed with gestational diabetes and treated with metformin (per routine clinical practice
Sponsors
Zuyderland Medisch Centrum
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Insulin treatment | 35-37 weeks gestation | requirement for additional insulin treatment |
| 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 |
| Dietary intake | 24-28 and 35-37 weeks gestation | Average energy intake, measured over 7 days using online dietary records |
Countries
Netherlands
Outcome results
None listed