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Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?

NCT04362540 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 189

Last updated 2026-03-30

No results posted yet for this study

Summary

The aim of this study is to utilise ultrasound, using an established method for detecting NAFLD, to determine whether the presence of NAFLD in women with GDM, detected during routine scanning, is a marker of deterioration in glycaemic status post-partum. We propose to assess the relationship between NAFLD and surrogates for insulin resistance as well as glycaemic status, insulin sensitivity and β-cell function, after delivery.

The study is not seeking to compare the incidence of T2DM between those with and without NAFLD. This would require a longer follow-up and larger cohort size. Instead, it aims to quantify the degree of early deterioration of glycaemic status in these groups using insulin resistance markers. This is a clinically important issue as a greater level of insulin resistance would in itself trigger clinical intervention, including vigilant follow-up and empowerment for proactive healthy life style changes, which have been shown to prevent diabetes development .

Conditions

  • Gestational Diabetes

Interventions

DIAGNOSTIC_TEST

MRI scan

On attendance to antenatal clinic with confirmed diagnosis of gestational diabetes based on OGTT and following informed consent: Ultrasound scan: Those with positive OGTT results (i.e. GDM positive) will attend an appointment for an ultrasound scan, as per routine practice. These women will,at that appointment, be assessed for presence/absence of NAFLD as well as undergoing their routine foetal assessment. This is a simple addendum to the existing scan, taking no more than 5 minutes. Participants will have been informed during the consent process that the results (regarding the presence / absence of NAFLD) will be compared to MRI after delivery.

Sponsors & Collaborators

  • Diabetes UK

    collaborator OTHER

  • University Hospitals of North Midlands NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-05
Primary Completion
2025-06-30
Completion
2026-12-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362540 on ClinicalTrials.gov