An observational study in Type 1 Diabetes Mellitus (T1D), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
Objectives :
Procedures : After participant information and verbal non-opposition, clinical, metabolic, biological and hepatic data will be obtained from routine care records. Liver steatosis and stiffness are assessed by transient elastography (FibroScan).
Outcomes and analyses :
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study arm: All consecutive adult patients living with type 1 diabetes who attend the day hospital units of the diabetology departments at Lariboisière and Bichat Hospitals (Paris) and undergo liver assessment using FibroScan as part of routine clinical care.
- Control arm: Data from patients living with type 2 diabetes (T2D) who were previously enrolled in the AngioSafe T2D cohort.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control arms with data from patients living with type 2 diabetes (T2D) who were previously included in the AngioSafe T2D cohort.
Study arm comprising all consecutive adult patients living with type 1 diabetes who attend the day hospital units of the diabetology departments at Lariboisière and Bichat Hospitals (Paris), during which they undergo liver assessment using FibroScan as part of routine clinical care.
Comparison of circulating immune-cell subset frequencies according to liver status in patients with type 1 diabetes
Frequencies of circulating immune-cell subsets, expressed as percentages of the relevant parent cell population, will be quantified by multiparameter flow cytometry. Measurements will be compared across three liver-status groups defined by FibroScan: no steatosis (CAP \< 250 dB/m and liver stiffness \< 8 kPa), MASLD without elevated liver stiffness (CAP ≥ 250 dB/m and liver stiffness \< 8 kPa), and MASLD with elevated liver stiffness (CAP ≥ 250 dB/m and liver stiffness ≥ 8 kPa).
Time frame: Baseline (single day-hospital visit).
Comparison of circulating immune-cell gene expression profiles according to liver status in patients with type 1 diabetes
Transcriptomic profiles of circulating immune cells will be assessed using gene expression analysis. Differential gene expression between liver-status groups will be evaluated using normalized gene expression measurements and statistical analyses, as specified in the study protocol.
Time frame: Baseline (single day-hospital visit)
Identification and characterization of inflammatory endotypes in patients with type 1 diabetes
To identify and characterize distinct inflammatory endotypes in patients with type 1 diabetes based on flow cytometry (FACS) data
Time frame: Baseline (single day-hospital visit)
Association between inflammatory profiles, inflammatory endotypes, and MASLD severity
Analyze variations in inflammatory profiles across these endotypes and their association with the development of MASLD, using flow cytometry (FACS) of biological data. FibroScan: no steatosis (CAP \< 250 dB/m and liver stiffness \< 8 kPa), MASLD without elevated liver stiffness (CAP ≥ 250 dB/m and liver stiffness \< 8 kPa), and MASLD with elevated liver stiffness (CAP ≥ 250 dB/m and liver stiffness ≥ 8 kPa).
Time frame: Baseline (single day-hospital visit)
Association between hepatic status, inflammatory endotypes, and cardiovascular risk
To investigate the association between hepatic status, as previously defined, inflammatory endotypes, and cardiovascular risk assessed using validated clinical cardiovascular risk prediction scores and the coronary artery calcium score, a marker of coronary atherosclerotic burden. Higher scores indicate greater cardiovascular risk.
Time frame: day 1, (single day-hospital visit)
Association between hepatic status, inflammatory endotypes, and diabetic foot ulcer risk
To investigate the association between hepatic status, as previously defined, inflammatory endotypes, and diabetic foot ulcer risk, assessed using standard clinical grading systems incorporating peripheral neuropathy, lower limb peripheral arterial disease, foot deformities, and history of previous ulcers or amputations.
Time frame: Day 1, (single day-hospital visit)
Comparison of inflammatory signatures between type 1 and type 2 diabetes
To compare inflammatory signatures associated with MASLD/MASH in patients with type 1 diabetes with those observed in patients with type 2 diabetes, using data from the existing AngioSafe T2D cohort.
Time frame: Day 1, (single day-hospital visit)
Prevalence of MASLD and MASH in patients with type 1 diabetes
To estimate the prevalence of MASLD and MASH among patients with type 1 diabetes in the study population.
Time frame: Day 1, (single day-hospital visit)
Risk factors associated with MASLD and MASH in patients with type 1 diabetes
To identify clinical, biological, and metabolic risk factors associated with the development of MASLD and MASH in patients with type 1 diabetes.
Time frame: Day 1, (single day-hospital visit)
Clinical and demographic characteristics of patients with type 1 diabetes according to hepatic status
To describe the clinical and demographic characteristics of patients with type 1 diabetes according to their hepatic status, assessed by FibroScan, using the following categories: * No steatosis: CAP \< 250 dB/m and liver stiffness \< 8 kPa. * MASLD without elevated liver stiffness: CAP ≥ 250 dB/m and liver stiffness \< 8 kPa. * MASLD with elevated liver stiffness: CAP ≥ 250 dB/m and liver stiffness ≥ 8 kPa.
Time frame: Day 1, (single day-hospital visit)
Plan to share: Undecided
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 24 months is below that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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