EMERGE Mothers and Kids

Recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT06327191
• Lead Sponsor: National University of Ireland, Galway, Ireland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-25
• Status Verified: 2024-07
• Study Start: 2024-07-09
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 321

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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.
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 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 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 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.

Trial Locations

Locations (1)

University Hospital Galway; 🇮🇪 Galway, Ireland