NCT03634098: Quid-Nash

Identification and Validation of Noninvasive Biomarkers of the Diagnosis and Severity of NASH in Type 2 Diabetics

Completed NA Last updated 8 December 2022

What this trial tests

NA trial testing new quantitative imaging techniques with contast products in Type2 Diabetes in 970 participants. Completed in 30 September 2022.

Timeline

25 October 2018

Primary endpoint
31 July 2022

30 September 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	970
Start date	25 October 2018
Primary completion	31 July 2022
Estimated completion	30 September 2022
Sites	1 location across France

Drugs / interventions tested

• new quantitative imaging techniques with contast products
• blood sample — full drug profile →
• second generation tests

Conditions studied

• Type2 Diabetes — all drugs for Type2 Diabetes →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and 15% progress to severe fibrosis or cirrhosis. These diseases are slowly progressive and asymptomatic. Their pathophysiology is poorly known. Management is hampered by the absence of a specific diagnostic marker, the need for invasive diagnostic procedures (liver biopsy), and the lack of established treatment.

QUID-NASH aims to develop a virtual liver biopsy in T2D participants, based on the identification of single or combined, multimodal, non-invasive biomarkers obtained by new quantitative imaging techniques (magnetic resonance and ultrafast ultrasound UFUS); and /or extensive clinical-biological phenotyping data; and/or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement these phenotyping data. This approach will also enable us to improve our understanding of pathophysiology (new signaling pathways, new therapeutic targets).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Potentials of Extracellular Vesicles for the Treatment of Diabetes and Diabetic Complications.
   Hu W, Song X, Yu H, Sun J, et al · · 2020 · cited 37× · PMID 32708290 · DOI 10.3390/ijms21145163
2. Prospective head-to-head comparison of non-invasive scores for diagnosis of fibrotic MASH in patients with type 2 diabetes.
   Castera L, Garteiser P, Laouenan C, Vidal-Trécan T, et al · · 2024 · cited 33× · PMID 38548067 · DOI 10.1016/j.jhep.2024.03.023
3. A new NRF2 activator for the treatment of human metabolic dysfunction-associated fatty liver disease.
   Hammoutene A, Laouirem S, Albuquerque M, Colnot N, et al · · 2023 · cited 24× · PMID 37663119 · DOI 10.1016/j.jhepr.2023.100845
4. Clinical Interest of Serum Alpha-2 Macroglobulin, Apolipoprotein A1, and Haptoglobin in Patients with Non-Alcoholic Fatty Liver Disease, with and without Type 2 Diabetes, before or during COVID-19.
   Deckmyn O, Poynard T, Bedossa P, Paradis V, et al · · 2022 · cited 12× · PMID 35327501 · DOI 10.3390/biomedicines10030699
5. Prospective external validation of a new non-invasive test for the diagnosis of non-alcoholic steatohepatitis in patients with type 2 diabetes.
   Poynard T, Paradis V, Mullaert J, Deckmyn O, et al · · 2021 · cited 12× · PMID 34398492 · DOI 10.1111/apt.16543
6. ACBP/DBI neutralization for the experimental treatment of fatty liver disease.
   Motiño O, Lambertucci F, Joseph A, Durand S, et al · · 2025 · cited 10× · PMID 39550516 · DOI 10.1038/s41418-024-01410-6
7. Prospective direct comparison of non-invasive liver tests in outpatients with type 2 diabetes using intention-to-diagnose analysis.
   Poynard T, Deckmyn O, Peta V, Paradis V, et al · · 2023 · cited 9× · PMID 37642160 · DOI 10.1111/apt.17688
8. Fat-Corrected Non-Gaussian Diffusion MRI for Liver Fibrosis Assessment in Metabolic Dysfunction-Associated Steatotic Liver Disease.
   Saïd O, Doblas S, Paradis V, Bedossa P, et al · · 2026 · cited 1× · PMID 41133428 · DOI 10.1002/jmri.70148