Status:
NOT_YET_RECRUITING
How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease
Non-Alcoholic Steato-Hepatitis (NASH)
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 w...
Detailed 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 mea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07133854
Start Date
September 1 2026
End Date
December 1 2028
Last Update
August 21 2025
Active Locations (1)
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1
Centre de recherche du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4