Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07133854

Opening soonNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionMetabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Steato-Hepatitis (NASH), Type 1 Diabetes Mellitus

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

hepatic NEFA uptakeAt baseline of Visit 2 (V2)

using 11C-palmitate PET

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Centre de recherche du CHUS🇨🇦 Sherbrooke, Quebec, Canada
Frédérique FrischContact
André C Carpentier, MDPrincipal Investigator