How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver (AGL14)

Université de Sherbrooke

Status: Begins enrollment in 6 months

Conditions: Type 1 Diabetes Mellitus; Metabolic Dysfunction-Associated Steatotic Liver Disease; Non-Alcoholic Steato-Hepatitis (NASH)

Treatments: Diagnostic Test: meal test; Diagnostic Test: Imaging PET/MRI; Diagnostic Test: Indirect calorimetry; Diagnostic Test: Stable isotope infusions

Study type: Interventional

Funder types: Other

Identifiers

NCT07133854

2026-5900

Details and patient eligibility

About

Steatotic liver disease associated with metabolic dysfunction (MASLD) is a disease caused by excess fat storage in the liver. Excessive fat delivery to the liver and MASLD typically occurs in people with abdominal obesity and type 2 diabetes. Type 1 diabetes (T1D) is also associated with a marked increase in the release of fat from adipose tissues and MASLD is increased in T1D and significantly increases the risk of heart, kidney and eye diseases.

Full description

It is a parallel study design between T1D and controls. The outcomes will be assessed between T1D vs. controls during the metabolic visit.

The metabolic visit will last 9 hours: it will be a test meal with perfusion of stable tracers, blood sampling, PET acquisitions using radiopharmaceuticals (18FTHA and 11C-palmitate) and MRI acquisitions.

In total, 32 participants will be recruited:

• 16 living with T1D and abdominal obesity
• 16 with normoglycemia

Enrollment: 32 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 16 individuals living with T1D and abdominal obesity, as defined by the International Diabetes Federation country/ethnic group-specific criteria (https://www.idf.org/e-library/consensus-statements/60- [1]. Treatment for T1D will be intensive insulin therapy on continuous pump perfusion with continuous glucose monitoring.
• 16 individuals with normoglycemia (i.e., HbA1c below 6.0%) matched for sex, age (± 5 years), waist circumference (± 3 cm), and menopausal status.

Exclusion criteria

• less than 70% of time in glycemic range (for T1D);
• history of primary dyslipidemia (LDL-cholesterol over 5 mmol/L or TG over 10 mmol/L) or uncontrolled high blood pressure (over 160/100 mmHg) precluding the withdrawal of lipid lowering and anti-hypertensive agents as per protocol;
• presence of overt cardiovascular, liver or renal disease (except microalbuminuria without reduced kidney function), or other uncontrolled medical conditions;
• use of any medication other than insulin that may affect lipid or carbohydrate metabolism and that cannot be stopped prior to testing;
• current or planned pregnancy within the next 6 months;
• any contraindication to MRI.
• Being allergic to eggs
• Smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day
• Having participated to a research study with exposure to radiation in the last year before the start of the study

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Group with Type 1 Diabetes

Experimental group

Description:

Participants will undergo a 9-hour postprandial metabolic study

Treatment:

Diagnostic Test: Stable isotope infusions

Diagnostic Test: Indirect calorimetry

Diagnostic Test: Imaging PET/MRI

Diagnostic Test: meal test

Group without Type 1 Diabetes

Experimental group

Description:

Participants will undergo a 9-hour postprandial metabolic study

Treatment:

Diagnostic Test: Stable isotope infusions

Diagnostic Test: Indirect calorimetry

Diagnostic Test: Imaging PET/MRI

Diagnostic Test: meal test