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

NCT04362540 | Active Not Recruiting

• 1 other identifier: 214643
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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

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

  6-12 weeks post partum

Secondary Outcomes (13)

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

  6-12 weeks post partum

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

  6-12 weeks post partum

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

  6-12 weeks post partum

• 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

  6-12 weeks post partum

• 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

  6-12 weeks post partum

Study Arms (1)

Pregnant women with GDM

Ultrasound liver scan in addition to routine foetal assessment (antenatal) Metabolic profile blood tests, Oral Glucose Tolerance Test, ELF blood test, repeat liver ultrasound scan and MRI scan (post partum)

Diagnostic Test: MRI scan

Interventions

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.

Also known as: OGTT, ELF, Ultrasound, Metabolic Profile

Pregnant women with GDM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with GDM as defined in routine practice, using standard oral glucose tolerance testing (OGTT). Women with confirmed GDM will be classified as either NAFLD-positive or NAFLD-negative on the basis of postpartum MRI scan.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diabetes UK: collaborator
• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

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

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Magnetic Resonance Imaging; Glucose Tolerance Test; Ultrasonography; Metabolome

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques, Endocrine; Investigative Techniques; Metabolism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: April 27, 2020
• Study Start: May 5, 2019
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)