Actively Recruiting

Phase Not Applicable
Age: 30Years - 70Years
All Genders
ID07246421

Mechanisms for Glucagon Resistance as Driver of Metabolic Associated Steatotic Liver Disease and Cardiovascular Disease in Humans With Type 2 Diabetes

Led by University of Aarhus · Updated on 2026-02-04

24

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

N

Novo Nordisk A/S

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how glucagon sensitivity differs in people with type 2 diabetes mellitus (T2DM), with or without metabolic associated fatty liver disease (MASLD). The study aims to find out if glucagon's effects on liver fat oxidation and suppression of VLDL-triglyceride secretion are impaired in these groups. It also explores whether glucagon resistance and MASLD correspond to unusual lipid and metabolite profiles in blood and fat tissue. Participants will receive infusions of low and high doses of glucagon along with somatostatin, insulin, and growth hormone replacements. They will also receive tracers for palmitate, VLDL-triglyceride, and glucose to study metabolic processes. PET scans using [11C]palmitate will be performed during the glucagon infusions to observe effects in tissues. During the study, participants will attend two short visits and one full-day visit. Assessments include body composition scans (DXA), MRI for liver fat measurement, blood tests, ultrasound to assess liver stiffness and scarring, fat tissue biopsies, and an 8-hour hormone and tracer infusion. Researchers will measure liver fatty acid oxidation rates, blood and tissue protein and lipid profiles, glucose production, fatty acid turnover, and VLDL-triglyceride kinetics. The total participation period spans several visits over the study duration.

CONDITIONS

Brief Title

Glucagon Resistance in Patients With MASLD and T2DM

Who Can Participate

Age: 30Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI greater than 26 kg/m²
  • Confirmed diagnosis of type 2 diabetes mellitus for at least 6 months before enrollment
  • For MASLD group: liver fat steatosis above 5.6% on MR spectroscopy
Not Eligible

You will not qualify if you...

  • Alcohol or other substance abuse exceeding 10 units per week
  • Smoking
  • Current or previous cancer
  • Blood donation within 3 months before study day
  • Participation in studies with radioactive isotopes within 3 months
  • Pregnancy
  • Severely uncontrolled type 2 diabetes (hemoglobin A1c ≥ 100 mmol/mol)
  • C-peptide levels below 200 pmol/L
  • Previous acute myocardial infarction
  • Symptoms of heart failure
  • Known systemic diseases except dyslipidemia and hypertension
  • Regular use of medications affecting lipid and glucose metabolism, including insulin and hormonal contraception, except specified washout allowances for statins, oral glucose-lowering therapy, antihypertensives, and weekly GLP-1 receptor agonists prior to study day

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive infusions of low and high dose glucagon with somatostatin, insulin, and growth hormone replacement, along with tracer infusions and imaging assessments.

1 study day with infusion and imaging procedures

Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Denmark, 8000

Actively Recruiting

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Research Team

K

Kia E. Fonfara, Medical Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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