Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes? (FLiP-GD2)

University Hospitals of North Midlands NHS Trust

Status: Enrolling

Conditions: Gestational Diabetes

Treatments: Diagnostic Test: MRI scan

Study type: Observational

Funder types: Other

Identifiers

NCT04362540

214643 (Other Identifier)

Details and patient eligibility

About

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 .

Enrollment: 95 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

95 participants in 1 patient group

Pregnant women with GDM

Description:

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)

Treatment:

Diagnostic Test: MRI scan