Metabolic Dysfunction-Associated Steatotic Liver DiseaseAGL14NCT07133854
How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver
A study testing Imaging PET/MRI, Stable isotope infusions and meal test in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Non-Alcoholic Steato-Hepatitis (NASH), run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Steato-Hepatitis (NASH), Type 1 Diabetes Mellitus
- What is being tested?
- Imaging PET/MRI, Stable isotope infusions and meal test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4
Frédérique Frisch, +1-819-346-1110 ext. 12394, frederique.frisch@usherbrooke.ca
André C Carpentier, MD
About this study
Official title: The Impact of Adipose Tissue Insulin Resistance and Abdominal Obesity on Hepatic Fatty Acid Metabolism in Type 1 Diabetes
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.
Read the 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
- Being tested
- Imaging PET/MRI, Stable isotope infusions, meal test, Indirect calorimetry
- Keywords
- abdominal obesity, Adipose tissue insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging PET/MRIDiagnostic 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 infusionsDiagnostic 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 testDiagnostic 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 calorimetryDiagnostic test
Indirect calorimetry (Vmax Series from Vyaire medical, licence # 22536), measured during10 minutes, every hour.
| Study group | Role | What they receive |
|---|---|---|
| Group with Type 1 Diabetes | Experimental | Participants will undergo a 9-hour postprandial metabolic study Receives: Diagnostic Test: Imaging PET/MRI; Diagnostic Test: Stable isotope infusions; Diagnostic Test: meal test; Diagnostic Test: Indirect calorimetry |
| Group without Type 1 Diabetes | Experimental | Participants will undergo a 9-hour postprandial metabolic study Receives: Diagnostic Test: Imaging PET/MRI; Diagnostic Test: Stable isotope infusions; Diagnostic Test: meal test; Diagnostic Test: Indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic NEFA uptake
using 11C-palmitate PET
Measured: At baseline of Visit 2 (V2)
Secondary outcomes (14)
postprandial hepatic Dietary Fatty Acid uptake
using 18F-FTHA
Measured: At V2 (from time 0 to +360 minutes)
Adipose Tissue DFA trapping and postprandial palmitate flux
Determined from the same static (whole-body) acquisition image using oral administration of [18F]-Fluoro-6-Thia- Heptadecanoic Acid (FTHA)
Measured: At V2 (from time 0 to +360 minutes)
hepatic fatty acid oxidation, esterification and secretion into VLDL
[11C]-Palmitate PET. Calculated from the same multicompartmental equation using liver [11C]-palmitate kinetics
Measured: At baseline
Hepatic triglyceride content
measured by MRI
Measured: At V2 (-200 minutes)
Endogenous Glucose production and meal glucose systemic flux
Apparition rate (µmol/min) of glucose from multicompartimental equation using intravenous perfusion and oral stable isotope tracer
Measured: At V2 (from time 0 to +360 minutes)
Insulin secretion
Determined by measuring C-peptide kinetics following the liquid meal
Measured: At V2 (from time 0 to +360 minutes)
Insulin resistance/ sensitivity
Determined by measuring circulating glucose and insulin following the liquid meal: glucose and insulin will be combined to give insulin resistance/sensitivity
Measured: At V2 (from time 0 to +360 minutes)
Glycerol turnover
calculated from [1,1,2,3,3-2H]-glycerol i.v.
Measured: At visit 2 (from time 0 to +360 minutes)
Total substrate utilisation
measured by using indirect calorimetry
Measured: At visit 2 (from time 0 to +360 minutes).
metabolite response
Colorimetric assay
Measured: At visit 2 (from time 0 to +360 minutes)
hormonal response
Multiplex assay
Measured: At visit 2 (from time 0 to +360 minutes)
plasma NEFA NEFA flux
calculated from i.v. stable isotope tracer (mass spectrometry).
Measured: At visit 2 (from time 0 to +360 minutes)
plasma distribution of DFA metabolites
calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA.
Measured: At visit 2 (from time 0 to +360 minutes)
Adipose tissue Insulin Resistance index
is calculated from measurement of postabsorptive concentrations of FFAs and insulin.
Measured: At visit 2 (from time 0 to +360 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
- Investigators
- André C Carpentier, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133854
- Sponsor's protocol ID
- 2026-5900
- Acronym
- AGL14
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Adipose Tissue Insulin Resistance and Abdominal Obesity on Hepatic Fatty Acid Metabolism in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07133854
- Acronym / sponsor ID
- AGL14 / 2026-5900
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Steato-Hepatitis (NASH), Type 1 Diabetes Mellitus
- Keywords
- abdominal obesity, Adipose tissue insulin resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with Type 1 Diabetes | Experimental | Diagnostic Test: Imaging PET/MRI, Diagnostic Test: Stable isotope infusions, Diagnostic Test: meal test, Diagnostic Test: Indirect calorimetryParticipants will undergo a 9-hour postprandial metabolic study |
| Group without Type 1 Diabetes | Experimental | Diagnostic Test: Imaging PET/MRI, Diagnostic Test: Stable isotope infusions, Diagnostic Test: meal test, Diagnostic Test: Indirect calorimetryParticipants will undergo a 9-hour postprandial metabolic study |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging PET/MRIMRI 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 | Group with Type 1 Diabetes, Group without Type 1 Diabetes |
| 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 | Group with Type 1 Diabetes, Group without Type 1 Diabetes |
| meal testA 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 | Group with Type 1 Diabetes, Group without Type 1 Diabetes |
| Indirect calorimetryIndirect calorimetry (Vmax Series from Vyaire medical, licence # 22536), measured during10 minutes, every hour. | Diagnostic test | Group with Type 1 Diabetes, Group without Type 1 Diabetes |
Primary outcome
hepatic NEFA uptake
Time frame: At baseline of Visit 2 (V2)
using 11C-palmitate PET
14 secondary outcomes
postprandial hepatic Dietary Fatty Acid uptake
Time frame: At V2 (from time 0 to +360 minutes)
Adipose Tissue DFA trapping and postprandial palmitate flux
Time frame: At V2 (from time 0 to +360 minutes)
hepatic fatty acid oxidation, esterification and secretion into VLDL
Time frame: At baseline
Hepatic triglyceride content
Time frame: At V2 (-200 minutes)
Endogenous Glucose production and meal glucose systemic flux
Time frame: At V2 (from time 0 to +360 minutes)
Insulin secretion
Time frame: At V2 (from time 0 to +360 minutes)
Insulin resistance/ sensitivity
Time frame: At V2 (from time 0 to +360 minutes)
Glycerol turnover
Time frame: At visit 2 (from time 0 to +360 minutes)
Total substrate utilisation
Time frame: At visit 2 (from time 0 to +360 minutes).
metabolite response
Time frame: At visit 2 (from time 0 to +360 minutes)
hormonal response
Time frame: At visit 2 (from time 0 to +360 minutes)
plasma NEFA NEFA flux
Time frame: At visit 2 (from time 0 to +360 minutes)
plasma distribution of DFA metabolites
Time frame: At visit 2 (from time 0 to +360 minutes)
Adipose tissue Insulin Resistance index
Time frame: At visit 2 (from time 0 to +360 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
André C Carpentier, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging PET/MRI, Stable isotope infusions and meal test in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Non-Alcoholic Steato-Hepatitis (NASH), run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédérique Frisch (+1-819-346-1110 ext. 12394, frederique.frisch@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatic NEFA uptake (time frame: At baseline of Visit 2 (V2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.