EMERGE Mothers and Kids

NCT06327191 | Recruiting

• 1 other identifier: 23-CRFG-21
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 1

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. 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. 2.to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
3. 3.to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
4. 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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (6)

• 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 10 years post the index pregnancy

• 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 10 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.

  Definitions of overweight and obesity are a body mass index of \>25 kg/m2 and \>30 kg/m2, respectively.

  Up to 10 years post the index pregnancy

• 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 10 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 at up to 10 years postpartum.

  Lipid levels will be assessed by measuring a fasting sample and will be analysed using local assays.

  Up to 10 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.

  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 10 years post the index pregnancy

Interventions

No intervention as the study is observational. OTHER

No intervention as the study is observational.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female participants only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Participation in the original EMERGE trial and consenting to further follow up.

You may not qualify if:

• EMERGE trial participants who did not provide consent for further follow up studies.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

University Hospital Galway

Galway, Ireland

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Fidelma Dunne, Prof

CONTACT

091 495 964; fidelma.dunne@universityofgalway.ie

Chloe Ryan

CONTACT

0861436415; chloe.ryan@universityofgalway.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: March 25, 2024
• Study Start: July 9, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)