EMERGE Mothers and Kids

Gestational Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327191
• Other study ID #: 23-CRFG-21
• Secondary ID: 23-CRFG-21
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: National University of Ireland, Galway, Ireland
• Contact: Fidelma Dunne, Prof
• Phone: 091 495 964
• Email: fidelma.dunne[@]universityofgalway.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 6 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 321
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• No intervention as the study is observational.
No intervention as the study is observational.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up..	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
Primary	To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome.	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	Up to 6 years post the index pregnancy
Primary	To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up.	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
Primary	To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension.	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
Primary	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.	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
Primary	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.	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