Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?
NCT ID: NCT04362540
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
95 participants
OBSERVATIONAL
2019-05-05
2025-12-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pregnant women diagnosed with GDM based on OGTT
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Diabetes UK
OTHER
University Hospitals of North Midlands NHS Trust
OTHER
Responsible Party
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Locations
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University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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214643
Identifier Type: -
Identifier Source: org_study_id
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