Gestational Diabetes
Conditions
Brief summary
The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality. The primary objectives of the EMERGE Mothers and Kids follow up study are: 1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 10 years post the index pregnancy; 2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration; 3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up; 4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.
Interventions
OTHERNo intervention as the study is observational.
No intervention as the study is observational.
Sponsors
National University of Ireland, Galway, Ireland
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Participation in the original EMERGE trial and consenting to further follow up.
Exclusion criteria
* EMERGE trial participants who did not provide consent for further follow up studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up.. | Up to 10 years post the index pregnancy | This will be evaluated using a 75g oral glucose tolerance test (OGTT) and a haemoglobin A1c (HbA1c). Cutoffs for diabetes, imparied fasting gluocse and impaired glucose tolerance will be in line with the American Diabetes Association diagnostic criteria (ADA 2023). |
| To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome. | Up to 10 years post the index pregnancy | Metabolic syndrome is defined as the presence of \>3 of the following risk factors (International Diabetetes Foundation 2009) * Fasting glucose \>5.6 mmol/L or diagnosed diabetes * High density lipoprotein (HDL) cholesterol of \<1.3 mmol/L or drug treatment for low HDL cholesterol * Triglyceride level of \>1.7 mmol/L or drug treatment for elevated triglycerides * Waist circumference of \>80cm * Hypertension with a blood pressure of \> 130/85 mmHg or drug treatment for hypertension |
| To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up. | Up to 10 years post the index pregnancy | Definitions of overweight and obesity are a body mass index of \>25 kg/m2 and \>30 kg/m2, respectively. |
| To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension. | Up to 10 years post the index pregnancy | Hypertension is defined as a blood pressure of \> 130 mmHg systolic or \>80 mmHg diatolic (Whelton 2017). |
| To examine the associations of GDM diagnosis, sum of fasting, 1-hour, and 2-hour glucose z-scores after 75-g load, insulin sensitivity, and lipid levels at 24-32 weeks' gestation with lipid levels at up to 10 years postpartum. | Up to 10 years post the index pregnancy | Lipid levels will be assessed by measuring a fasting sample and will be analysed using local assays. |
| To determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds. | Up to 10 years post the index pregnancy | Obesity will be defined as a BMI of \>95th percentile or BMI \> 30 kg/m2 (whichever is lower) for children 2 years and older. Overweight will be defined as a BMI of \>85th percentile. Weight for height gender specific growth charts will be used for children \<2 years of age and a weight-for-height which is \>95th centile will be considered obese. Overweight wil be defined as a BMI of \>85th percentile. |
Countries
Ireland
Outcome results
None listed