Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2026-01-01
2028-07-31
Brief Summary
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The main questions it aims to answer are:
1. Is the sensitivity to glucagon with respect to hepatic FA oxidation and suppression of VLDL-TG secretion impaired in humans with T2DM and MASLD?
2. Is glucagon resistance and MASLD reflected in an aberrated lipidomic/metabolomic profile in blood and adipose tissue?
Researchers will compare patients with T2DM with and without MASLD to see if the response to basal and high levels of glucagon differs between the groups.
Participants will attend 2 short visits and 1 full-day visit, including:
* Body scan (DXA) to check fat and bone composition
* MRI to measure liver fat.
* Blood tests.
* Ultrasound to check liver stiffness and scarring.
* Fat biopsies
* 8-hour hormone (including glucagon) and tracer infusion
* PET-CT scans
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Subjects with T2DM and MR spectroscopy verified NO steatosis
Glugagon
Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.
\[11C\]palmitate PET during low and high dose glucagon.
Subjects with T2DM and MR spectroscopy verified steatosis
Glugagon
Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.
\[11C\]palmitate PET during low and high dose glucagon.
Interventions
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Glugagon
Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.
\[11C\]palmitate PET during low and high dose glucagon.
Eligibility Criteria
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Inclusion Criteria
* confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) min. 6 months prior enrollment
* steatosis FF% \> 5,6% on MR spectroscopy for MAFLD group
Exclusion Criteria
* Smoking
* Current or previous malignant disease
* Blood donation within the last 3 months prior to the study day
* Participation in studies involving radioactive isotopes within the past 3 months
* Pregnancy
* Severely dysregulated type 2 diabetes mellitus (haemoglobin A1c ≥ 100 mmol/mol)
* C-peptide \< 200 pmol/L
* Previous acute myocardial infarction (AMI)
* Clinical symptoms of heart failure
* Current or previous malignant disease
* Known ongoing systemic disease, except for dyslipidaemia and hypertension
* Regular use of medication that may affect lipid and glucose metabolism, including insulin treatment, regular use of over-the-counter medications, and hormonal contraception. Exceptions:
1. Participants treated with statins may be included following a 2-week washout period prior to the experimental study day.
2. Participants receiving oral glucose-lowering therapy for T2DM and antihypertensive medication may be included provided that medication is withheld on the study day only.
3. Participants receiving weekly injectable glucagon-like peptide-1 receptor agonists (GLP-1 analogues) may be included following a 1-week washout period prior to the study day.
30 Years
70 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0092321
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MASLD_GLUCA2025
Identifier Type: -
Identifier Source: org_study_id
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