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NCT Number: NCT04362540

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

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 .

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 and over
  • Pregnant women diagnosed with GDM based on OGTT

Exclusion criteria

  • Women with known type 1 or type 2 diabetes prior to pregnancy
  • Women with known history of liver disease including alcoholic liver disease
  • Women unable or unwilling to consent to be part of the study
  • Women with contraindication to MRI

Treatment and study plan

MRI scan

Diagnostic Test

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.

Other names: OGTT, ELF, Ultrasound, Metabolic Profile

Primary outcomes

  1. The primary outcome measure for the study will be the mean difference in values of the HOMA-IR (as a surrogate for insulin resistance) in those with NAFLD vs. those without NAFLD 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

    To determine whether the presence of NAFLD during pregnancy in women with gestational diabetes mellitus is a marker of worse metabolic profile (insulin resistance).

Secondary outcomes

  1. Comparison of HbA1c and fasting glucose (standard markers of dysglycaemia) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  2. Comparison of disposition index (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  3. Comparison of QUICKI (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  4. Comparison of insulin and nonesterified fatty acid levels (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  5. Comparison of fasting levels from a 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  6. Comparison of area-under-the-curve from 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  7. Comparison of ELF blood test results (advanced marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  8. Comparison of liver function tests (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  9. Comparison of Body Mass Index (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  10. Comparison of waist circumference (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  11. Comparison of alcohol history in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum

    Time frame: 6-12 weeks post partum

  12. The presence of fat in the liver using a liver ultrasound scan at baseline and 6-12 weeks post partum.

    Time frame: 6-12 weeks post partum

  13. MRI scan to confirm the presence of NAFLD at 6-12 weeks post partum.

    Time frame: 6-12 weeks post partum

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Collaborators

  • Diabetes UK

Registry information

Acronym: FLiP-GD2

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Apr 27, 2020
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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