Clinical trial NCT06327191: EMERGE Mothers and Kids
Official title: EMERGE Mothers and Kids: a Longitudinal Cohort Study of Mothers and Kids Enrolled in the Randomized Placebo Controlled Trial of Metformin in Women With GDM (EMERGE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 321
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population for this longitudinal cohort study is women who participated in the EMERGE randomised controlled trial and who consented to be contacted about further follow-up studies.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up..
timeFrame: Up to 10 years post the index pregnancy
measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome.
timeFrame: Up to 10 years post the index pregnancy
measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up.
timeFrame: Up to 10 years post the index pregnancy
measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension.
timeFrame: Up to 10 years post the index pregnancy
measure: 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.
timeFrame: Up to 10 years post the index pregnancy
measure: 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.
timeFrame: Up to 10 years post the index pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: University Hospital Galway
Study officials:
References: