NCT07246421

Brief Summary

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:

  • 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

February 4, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

November 17, 2025

Last Update Submit

February 3, 2026

Conditions

Type 2 Diabetes (T2DM)Metabolic Associated Fatty Liver Disease

Keywords

MASLDGlucagonGlucagon Resistance

Outcome Measures

Primary Outcomes (2)

  • Hepatic FFA oxidation rate (µmol/100Ml/min)

    Measured using \[11C\]palmitate positron-emission tomography (PET)

    30 minutes at steady-state

  • Blood and adipose tissue proteomic and lipidomic profiles

    Mass spectrometry-based lipidomic/proteomic profiles of paired adipose and plasma samples.

    30 minutes after steady-state

Secondary Outcomes (3)

  • Endogen glucose production (mmol/kg/min)

    30 minutes at steady-state

  • Fatty acid turnover (µmol/min)

    30 minutesat steady-state

  • VLDL-triglyceride kinetics (appearance rate (µmol/min) and oxidation (µmol/min))

    30 minutes at steady-state

Study Arms (2)

Subjects with T2DM and MR spectroscopy verified NO steatosis

ACTIVE COMPARATOR
Other: Glugagon

Subjects with T2DM and MR spectroscopy verified steatosis

ACTIVE COMPARATOR
Other: Glugagon

Interventions

GlugagonOTHER

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 NO steatosisSubjects with T2DM and MR spectroscopy verified steatosis

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Kia E. Fonfara, Medical Doctor

CONTACT

+4524607114kia.eistrup@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

January 29, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

February 4, 2026

Record last verified: 2025-12

Locations

DK(1)