- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327191
EMERGE Mothers and Kids
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)
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:
- to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 6 years post the index pregnancy;
- to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
- to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fidelma Dunne, Prof
- Phone Number: 091 495 964
- Email: fidelma.dunne@universityofgalway.ie
Study Contact Backup
- Name: Chloe Ryan
- Phone Number: 0861436415
- Email: chloe.ryan@universityofgalway.ie
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up..
Time Frame: Up to 6 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).
|
Up to 6 years post the index pregnancy
|
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome.
Time Frame: Up to 6 years post the index pregnancy
|
Metabolic syndrome is defined as the presence of >3 of the following risk factors (International Diabetetes Foundation 2009)
|
Up to 6 years post the index pregnancy
|
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up.
Time Frame: Up to 6 years post the index pregnancy
|
Definitions of overweight and obesity are a body mass index of >25 kg/m2 and >30 kg/m2, respectively.
|
Up to 6 years post the index pregnancy
|
To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension.
Time Frame: Up to 6 years post the index pregnancy
|
Hypertension is defined as a blood pressure of > 130 mmHg systolic or >80 mmHg diatolic (Whelton 2017).
|
Up to 6 years post the index pregnancy
|
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 3-6 years postpartum.
Time Frame: Up to 6 years post the index pregnancy
|
Lipid levels will be assessed by measuring a fasting sample and will be analysed using local assays.
|
Up to 6 years post the index pregnancy
|
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.
Time Frame: Up to 6 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. |
Up to 6 years post the index pregnancy
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-CRFG-21 (Other Identifier: Clinical Research Facility Galway (CRFG) study number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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