Understanding NAFLD in patients with Type 1 Diabetes
Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus Obtained Via a Non-invasive Screening Protocol
This study looks at how common nonalcoholic fatty liver disease is in adults with type 1 diabetes and uses tests like ultrasound and MRI to learn more about it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT04664036 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence and characteristics of nonalcoholic fatty liver disease (NAFLD) in adults with type 1 diabetes. It will utilize multiple non-invasive screening techniques, including ultrasound and MRI, to diagnose and stage NAFLD in a large cohort of patients. Additionally, the study will evaluate cardiovascular risk factors and other metabolic parameters, creating a biobank for future research. The goal is to enhance understanding of the relationship between NAFLD and type 1 diabetes, ultimately improving patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with type 1 diabetes who do not have secondary liver diseases.
Not a fit: Patients with secondary liver diseases, excessive alcohol usage, or those on steatogenic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better screening and management strategies for NAFLD in patients with type 1 diabetes, potentially reducing associated health risks.
How similar studies have performed: While studies on NAFLD in diabetes exist, this approach utilizing multiple non-invasive diagnostic tools in a specific cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes * Adult age * Informed consent given Exclusion Criteria: * Secondary liver disease * Excess alcohol usage * Pregnancy * Use of steatogenic medication * Active cancer or oncological treatment * History of organ transplantation
Where this trial is running
Edegem, Antwerp
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Christophe De Block, M.D., PhD — Universiteit Antwerpen
- Study coordinator: Jonathan Mertens, M.D.
- Email: jonathan.mertens@uza.be
- Phone: +328217304
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.