Aarhus University Hospital
Aarhus, 8000, Denmark
Location status: Recruiting
Recruiting
NCT Number: NCT07246421
Glucagon Resistance in Patients With MASLD and T2DM
The goal of this clinical trial is to investigate the sensitivity to glucagon in patients with type 2 diabetes mellitus (T2DM), with and without metabolic associated fatty liver disease (MASLD).
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
30 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- BMI > 26 kg/m²
- 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
- Alcohol abuse (>10 units per week for both sexes) or other substance abuse
- 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:
- Participants treated with statins may be included following a 2-week washout period prior to the experimental study day.
- Participants receiving oral glucose-lowering therapy for T2DM and antihypertensive medication may be included provided that medication is withheld on the study day only.
- 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.
Treatment and study plan
Glugagon
OtherInfusion 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.
Primary outcomes
-
Hepatic FFA oxidation rate (µmol/100Ml/min)
Time frame: 30 minutes at steady-state
Measured using [11C]palmitate positron-emission tomography (PET)
-
Blood and adipose tissue proteomic and lipidomic profiles
Time frame: 30 minutes after steady-state
Mass spectrometry-based lipidomic/proteomic profiles of paired adipose and plasma samples.
Secondary outcomes
-
Endogen glucose production (mmol/kg/min)
Time frame: 30 minutes at steady-state
3-3H glucose tracer technique
-
Fatty acid turnover (µmol/min)
Time frame: 30 minutesat steady-state
Infusion af [9,10-3H] palmitate and measurement of specific activity
-
VLDL-triglyceride kinetics (appearance rate (µmol/min) and oxidation (µmol/min))
Time frame: 30 minutes at steady-state
Ex vivo labeled VLDL [14C]-triolein tracer technique. Oxidation is measured by specific activity in exhaled air.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Aarhus
Other
Collaborators
- Novo Nordisk A/S
Registry information
Official study title
Mechanisms for Glucagon Resistance as Driver of Metabolic Associated Steatotic Liver Disease and Cardiovascular Disease in Humans With Type 2 Diabetes
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Nov 24, 2025
- Registry last updated
- Feb 4, 2026
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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