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Immunological Signatures of MASLD and MASH in Patients With Type 1 Diabetes

Key facts

Where
Paris, FranceSee the site

Where in France

  • Hospital, AP-HP, 2 rue Ambroise Paré, Paris, France (coordinating center) - Department of Diabetology, Bichat Hospital, AP-HP, 46 Rue Henri Huchard, Paris, FranceParis, FranceNo longer taking part

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Trial details

Who runs it
Assistance Publique - Hôpitaux de Paris
Trial code
NCT07927647
Record updated
10 November 2026
Original description
MASLD and its inflammatory form, MASH, are major public health concerns due to their high prevalence and association with hepatic and cardiovascular morbidity and mortality. Although extensively studied in type 2 diabetes (T2D), their pathophysiology in type 1 diabetes (T1D) remains poorly understood. Given the differences in immune mechanisms between T1D, primarily involving adaptive immunity, and T2D, associated with chronic innate immune activation, MASH may involve distinct immunoinflammatory pathways depending on the type of diabetes. This cross-sectional study aims to identify specific immunological and transcriptomic signatures associated with MASLD/MASH in patients with T1D and compare them with those observed in T2D, ultimately improving understanding of disease mechanisms and hepatic and cardiovascular risk stratification.Read full original descriptionShow less

MASLD and its inflammatory form, MASH, are major public health concerns due to their high prevalence and association with hepatic and cardiovascular morbidity and mortality. Although extensively studied in type 2 diabetes (T2D), their pathophysiology in type 1 diabetes (T1D) remains poorly understood. Given the differences in immune mechanisms between T1D, primarily involving adaptive immunity, and T2D, associated with chronic innate immune activation, MASH may involve distinct immunoinflammatory pathways depending on the type of diabetes. This cross-sectional study aims to identify specific immunological and transcriptomic signatures associated with MASLD/MASH in patients with T1D and compare them with those observed in T2D, ultimately improving understanding of disease mechanisms and hepatic and cardiovascular risk stratification.

Inclusion: Male or female subject aged > 18 years; Subject living with type 1 diabetes (T1D) in the study arm, with a FibroScan examination scheduled during a day hospital (DH) visit; Subject living with type 2 diabetes (T2D) who has previously participated in the AngioSafe T2D cohort, in the control arm; Subject who verbally agrees to participate in the study (i.e., expresses no objection), after having been informed and given a reasonable period for consideration.

Exclusion: Subject with another chronic inflammatory disease (such as psoriasis, sarcoidosis, rheumatoid arthritis, inflammatory bowel disease, etc.); Subject with conditions affecting the immune system (cancer, hematological malignancies, HIV); Subject with an acute biological inflammatory syndrome (CRP > 10 mg/L; leukocyte count > 12 G/L) during the day hospital (DH) visit; Subject who has expressed opposition to participation in the study or to the reuse of their data.

ClinicalTrials.gov NCT07927647