Trials / Not Yet Recruiting
Not Yet RecruitingNCT07133854
How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver
The Impact of Adipose Tissue Insulin Resistance and Abdominal Obesity on Hepatic Fatty Acid Metabolism in Type 1 Diabetes
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Université de Sherbrooke · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
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 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.
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 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
Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- Non-Alcoholic Steato-Hepatitis (NASH)
- Type 1 Diabetes Mellitus
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Imaging PET/MRI | 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. |
| DIAGNOSTIC_TEST | Stable isotope infusions | \[6,6 D2\]-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. |
| DIAGNOSTIC_TEST | meal 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. |
| DIAGNOSTIC_TEST | Indirect calorimetry | Indirect calorimetry (Vmax Series from Vyaire medical, licence # 22536), measured during10 minutes, every hour. |
Timeline
- Start date
- 2026-09-01
- Primary completion
- 2027-09-01
- Completion
- 2028-12-01
- First posted
- 2025-08-21
- Last updated
- 2025-08-21
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT07133854. Inclusion in this directory is not an endorsement.