Immunological Signatures of MASLD and MASH in Patients With Type 1 Diabetes
NCT07927647, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Immunological Signatures of MASLD and MASH in Patients With Type 1 Diabetes | ClinicalTrials.gov |
| NCT number | NCT07927647 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 1,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Type 1 Diabetes Mellitus (T1D), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Type 2 Diabetes Mellitus (T2D) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Comparison of circulating immune-cell subset frequencies according to liver status in patients with type 1 diabetes | Baseline (single day-hospital visit). | 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). | ClinicalTrials.gov |
| Primary | Comparison of circulating immune-cell gene expression profiles according to liver status in patients with type 1 diabetes | Baseline (single day-hospital visit) | 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. | ClinicalTrials.gov |
| Secondary | Identification and characterization of inflammatory endotypes in patients with type 1 diabetes | Baseline (single day-hospital visit) | To identify and characterize distinct inflammatory endotypes in patients with type 1 diabetes based on flow cytometry (FACS) data | ClinicalTrials.gov |
| Secondary | Association between inflammatory profiles, inflammatory endotypes, and MASLD severity | Baseline (single day-hospital visit) | 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). | ClinicalTrials.gov |
| Secondary | Association between hepatic status, inflammatory endotypes, and cardiovascular risk | day 1, (single day-hospital visit) | 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. | ClinicalTrials.gov |
| Secondary | Association between hepatic status, inflammatory endotypes, and diabetic foot ulcer risk | Day 1, (single day-hospital visit) | 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. | ClinicalTrials.gov |
| Secondary | Comparison of inflammatory signatures between type 1 and type 2 diabetes | Day 1, (single day-hospital visit) | 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. | ClinicalTrials.gov |
| Secondary | Prevalence of MASLD and MASH in patients with type 1 diabetes | Day 1, (single day-hospital visit) | To estimate the prevalence of MASLD and MASH among patients with type 1 diabetes in the study population. | ClinicalTrials.gov |
| Secondary | Risk factors associated with MASLD and MASH in patients with type 1 diabetes | Day 1, (single day-hospital visit) | To identify clinical, biological, and metabolic risk factors associated with the development of MASLD and MASH in patients with type 1 diabetes. | ClinicalTrials.gov |
| Secondary | Clinical and demographic characteristics of patients with type 1 diabetes according to hepatic status | Day 1, (single day-hospital visit) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)