Centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4, Canada
NCT Number: NCT07133854
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.
Trial opening soon.
Get Notified21 year and older
All sexes
Interventional
Not applicable
Sherbrooke, Quebec, J1H 5N4, Canada
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
[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.
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 (Vmax Series from Vyaire medical, licence # 22536), measured during10 minutes, every hour.
Time frame: At baseline of Visit 2 (V2)
using 11C-palmitate PET
Time frame: At V2 (from time 0 to +360 minutes)
using 18F-FTHA
Time frame: At V2 (from time 0 to +360 minutes)
Determined from the same static (whole-body) acquisition image using oral administration of [18F]-Fluoro-6-Thia- Heptadecanoic Acid (FTHA)
Time frame: At baseline
[11C]-Palmitate PET. Calculated from the same multicompartmental equation using liver [11C]-palmitate kinetics
Time frame: At V2 (-200 minutes)
measured by MRI
Time frame: At V2 (from time 0 to +360 minutes)
Apparition rate (µmol/min) of glucose from multicompartimental equation using intravenous perfusion and oral stable isotope tracer
Time frame: At V2 (from time 0 to +360 minutes)
Determined by measuring C-peptide kinetics following the liquid meal
Time frame: At V2 (from time 0 to +360 minutes)
Determined by measuring circulating glucose and insulin following the liquid meal: glucose and insulin will be combined to give insulin resistance/sensitivity
Time frame: At visit 2 (from time 0 to +360 minutes)
calculated from [1,1,2,3,3-2H]-glycerol i.v.
Time frame: At visit 2 (from time 0 to +360 minutes).
measured by using indirect calorimetry
Time frame: At visit 2 (from time 0 to +360 minutes)
Colorimetric assay
Time frame: At visit 2 (from time 0 to +360 minutes)
Multiplex assay
Time frame: At visit 2 (from time 0 to +360 minutes)
calculated from i.v. stable isotope tracer (mass spectrometry).
Time frame: At visit 2 (from time 0 to +360 minutes)
calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA.
Time frame: At visit 2 (from time 0 to +360 minutes)
is calculated from measurement of postabsorptive concentrations of FFAs and insulin.
Contact information is provided by the study sponsor or research team.
Université de Sherbrooke
Other
The Impact of Adipose Tissue Insulin Resistance and Abdominal Obesity on Hepatic Fatty Acid Metabolism in Type 1 Diabetes
Acronym: AGL14
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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