Clinical Trial

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

Study acronym: FLiP-GD2
Active, Not Recruiting
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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 .
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-04-22; most recent amendment 2026-03-25.
Status change: Recruiting → Active, Not Recruiting 2026-03-25
Trial Details
NCT Number NCT04362540
Lead Sponsor University Hospitals of North Midlands NHS Trust
Collaborators: Diabetes UK
Conditions Gestational Diabetes
Enrollment 189 participants
Start Date 2019-05-05
Primary Completion 2025-06-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-30