Investigating liver fat as a marker for post-pregnancy diabetes risk in women with gestational diabetes
Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?
This study is testing whether measuring liver fat in women who had gestational diabetes can help predict their risk of developing diabetes after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospitals of North Midlands NHS Trust Academic / other |
| Locations | 1 site (Stoke-on-Trent, Staffordshire) |
| Trial ID | NCT04362540 on ClinicalTrials.gov |
What this trial studies
This observational study aims to use ultrasound to detect non-alcoholic fatty liver disease (NAFLD) in women diagnosed with gestational diabetes mellitus (GDM) and assess its relationship with glycaemic status and insulin resistance after delivery. By evaluating the presence of NAFLD during routine scans, the study seeks to quantify early deterioration in glycaemic control, which could indicate a need for clinical intervention. The focus is on understanding how liver fat may serve as a marker for future diabetes risk, rather than comparing diabetes incidence between groups. This research could empower women to make proactive lifestyle changes to prevent diabetes development.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and over who have been diagnosed with gestational diabetes based on an oral glucose tolerance test.
Not a fit: Patients with pre-existing type 1 or type 2 diabetes, known liver disease, or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify women at higher risk for diabetes after pregnancy, allowing for early intervention and lifestyle modifications.
How similar studies have performed: While this approach is novel in its specific focus on NAFLD as a marker for glycaemic deterioration post-pregnancy, similar studies have shown the importance of monitoring insulin resistance in gestational diabetes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stoke-on-Trent, Staffordshire
- University Hospitals of North Midlands NHS Trust — Stoke-on-Trent, Staffordshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Keira Watts
- Email: keira.watts@uhnm.nhs.uk
- Phone: 01782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.