Clinical trial NCT04362540: Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?
Official title: Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
Collaborators: name: Diabetes UK
First posted: 2020-04-27
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 .


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6-12 weeks post partum
Secondary outcomes:
measure: Comparison of HbA1c and fasting glucose (standard markers of dysglycaemia) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
timeFrame: 6-12 weeks post partum
measure: Comparison of disposition index (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
timeFrame: 6-12 weeks post partum
measure: Comparison of QUICKI (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
timeFrame: 6-12 weeks post partum
measure: 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
timeFrame: 6-12 weeks post partum
measure: 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
timeFrame: 6-12 weeks post partum
measure: 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
timeFrame: 6-12 weeks post partum
measure: 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
timeFrame: 6-12 weeks post partum
measure: 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
timeFrame: 6-12 weeks post partum
measure: 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
timeFrame: 6-12 weeks post partum
measure: 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
timeFrame: 6-12 weeks post partum
measure: Comparison of alcohol history in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum
timeFrame: 6-12 weeks post partum
measure: The presence of fat in the liver using a liver ultrasound scan at baseline and 6-12 weeks post partum.
timeFrame: 6-12 weeks post partum
measure: MRI scan to confirm the presence of NAFLD at 6-12 weeks post partum.
timeFrame: 6-12 weeks post partum
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
Study officials:
References: