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

Gestational Diabetes Clinical Trial

— FLiP-GD2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04362540
• Other study ID #: 214643
• Status: Recruiting
• Start date: May 5, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: University Hospitals of North Midlands NHS Trust
• Contact: Keira Watts
• Phone: 01782
• Email: keira.watts[@]uhnm.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent	Staffordshire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust	Diabetes UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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		6-12 weeks post partum
Secondary	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		6-12 weeks post partum
Secondary	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		6-12 weeks post partum
Secondary	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		6-12 weeks post partum
Secondary	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		6-12 weeks post partum
Secondary	Comparison of alcohol history in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum		6-12 weeks post partum
Secondary	The presence of fat in the liver using a liver ultrasound scan at baseline and 6-12 weeks post partum.		6-12 weeks post partum
Secondary	MRI scan to confirm the presence of NAFLD at 6-12 weeks post partum.		6-12 weeks post partum