Glucagon resistance in MASLD and type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare adults with type 2 diabetes who have MASLD to those without MASLD to determine whether glucagon's effects on hepatic fatty acid oxidation and suppression of VLDL-TG secretion differ between groups. Participants attend two short visits and one full-day visit for DXA body composition, MRI liver fat measurement, ultrasound elastography, blood tests, adipose tissue biopsies, and PET-CT imaging. During the full-day visit an 8-hour hormone and tracer infusion including basal and high glucagon phases will measure dynamic metabolic responses and collect lipidomic/metabolomic data. The protocol integrates imaging, tracer kinetics, and molecular profiling to characterize a potential glucagon-resistant phenotype in humans with T2DM and MASLD.

Why it matters

Who can join: the full rules

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:

  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.

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting

Study contacts

• Study coordinator: Kia E. Fonfara, Medical Doctor
• Email: kia.eistrup@clin.au.dk
• Phone: +4524607114

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.