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

Sponsor
Université de Sherbrooke
Study ID
NCT07133854
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Imaging PET/MRI — DIAGNOSTIC_TEST
    MRI using 1H-MRS and Dixon sequences on a 3 T clinical MRI system (Ingenia, Philips Healthcare, Best, the Netherlands) will be performed. \[11C\]-palmitate: 1 x i.v. injection of 175 MBq followed by TEP imaging. \[18F\]-FTHA: oral administration of 75 MBq followed by TEP imaging.
  • Stable isotope infusions — DIAGNOSTIC_TEST
    \[6,6 D2\]-glucose infusion (0.22 µmol/kg/min, preceded by a bolus of 22 µmol/kg) will start from -180 until time + 360. \[1,1,2,3,3-2H\]-glycerol (0.05 µmol/kg/min.) and of \[7,7,8,8-2H\] palmitate (0.01 µmol/kg/min) will start from time -60 until time +360.
  • meal test — DIAGNOSTIC_TEST
    A liquid meal will be administered at time 0. The liquid meal (400 ml) energy breakdown is 50% (101g) from glucose, 33% (31g) from fat, and 17% (40g) from protein; participants will consume the 400 ml in 4 aliquots of 100 ml over 20 min, supplemented with 0.9 g of U-\[13C\]-glucose and 9 μmol/kg lean mass of \[U-13C\]-palmitate.
  • Indirect calorimetry — DIAGNOSTIC_TEST
    Indirect calorimetry (Vmax Series from Vyaire medical, licence # 22536), measured during10 minutes, every hour.

Study Details

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.

Key Dates

First listed
Aug 21, 2025
Start date
Sep 30, 2026
Status verified
Jul 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group with Type 1 Diabetes
    Participants will undergo a 9-hour postprandial metabolic study
  • Experimental: Group without Type 1 Diabetes
    Participants will undergo a 9-hour postprandial metabolic study

Primary Outcome Measure

hepatic NEFA uptake [ Time Frame: At baseline of Visit 2 (V2) ]

Central Contacts

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