Mechanisms for Glucagon Resistance as Driver of Metabolic Associated Steatotic Liver Disease and Cardiovascular Disease in Humans With Type 2 Diabetes
Investigating Glucagon's Role in Liver Fat and Heart Disease in Type 2 Diabetes
Plain English Summary
Glucagon Resistance in Patients With MASLD and T2DM is a Not Applicable clinical trial sponsored by University of Aarhus studying Metabolic Associated Fatty Liver Disease, Type 2 Diabetes (T2DM). This study tests how the hormone glucagon affects fat metabolism in the liver and blood in people with type 2 diabetes, especially those with fatty liver disease. It is for adults with type 2 diabetes, who may or may not have metabolic associated fatty liver disease (MASLD). Participation involves 2 short visits and 1 full-day visit with scans, blood tests, and hormone infusions. There are no direct alternative treatments being tested in this study; it focuses on understanding the disease. The trial aims to enroll 24 participants.
Official 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: 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
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with a confirmed diagnosis of type 2 diabetes for at least 6 months. Individuals with MASLD must have a liver fat percentage greater than 5.6%. Participants must have a BMI over 26. People with a history of heart attack, heart failure symptoms, current or past cancer, or severe diabetes (HbA1c >= 100 mmol/mol) cannot join. This trial is studying Metabolic Associated Fatty Liver Disease, Type 2 Diabetes (T2DM), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes will show how glucagon influences the liver's ability to process fats and how this is reflected in blood and fat tissue, helping to understand disease mechanisms. The specific primary outcome measures are: Hepatic FFA oxidation rate (µmol/100Ml/min) (30 minutes at steady-state); Blood and adipose tissue proteomic and lipidomic profiles (30 minutes after steady-state). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to uncover why some people with type 2 diabetes develop fatty liver and heart issues, addressing a gap in understanding these interconnected conditions. This research targets Metabolic Associated Fatty Liver Disease, Type 2 Diabetes (T2DM), where improved treatment options are needed.
Investor Insight
This early-phase research from a university sponsor focuses on a fundamental biological mechanism, potentially paving the way for future drug development in the large MASLD and T2DM markets.
Is This Trial Right for Me?
Ask your doctor if this study is right for you, especially regarding your diabetes and liver health. Be prepared for multiple visits, including a full day of tests and infusions. You may need to temporarily stop certain diabetes or blood pressure medications on study days. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 24 participants
Interventions
- OTHER: 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.
Primary Outcomes
- Hepatic FFA oxidation rate (µmol/100Ml/min) (30 minutes at steady-state)
- Blood and adipose tissue proteomic and lipidomic profiles (30 minutes after steady-state)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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.
Trial Locations
- Aarhus University Hospital, Aarhus, Denmark
Frequently Asked Questions
What is clinical trial NCT07246421?
NCT07246421 is a Not Applicable INTERVENTIONAL study titled "Glucagon Resistance in Patients With MASLD and T2DM." It is currently recruiting and is sponsored by University of Aarhus. The trial targets enrollment of 24 participants.
What conditions does NCT07246421 study?
This trial investigates treatments for Metabolic Associated Fatty Liver Disease, Type 2 Diabetes (T2DM). The primary condition under study is Metabolic Associated Fatty Liver Disease.
What treatments are being tested in NCT07246421?
The interventions being studied include: Glugagon (OTHER). 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.
What does Not Applicable mean for NCT07246421?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07246421?
This trial is currently "Recruiting." It started on 2026-01-29. The estimated completion date is 2028-07-31.
Who is sponsoring NCT07246421?
NCT07246421 is sponsored by University of Aarhus. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07246421?
The trial aims to enroll 24 participants. The trial is currently recruiting and accepting new participants.
How is NCT07246421 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07246421?
The primary outcome measures are: Hepatic FFA oxidation rate (µmol/100Ml/min) (30 minutes at steady-state); Blood and adipose tissue proteomic and lipidomic profiles (30 minutes after steady-state). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07246421 being conducted?
This trial is being conducted at 1 site, including Aarhus (Denmark).
Where can I find official information about NCT07246421?
The official record for NCT07246421 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07246421. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07246421 testing in simple terms?
This study tests how the hormone glucagon affects fat metabolism in the liver and blood in people with type 2 diabetes, especially those with fatty liver disease. It is for adults with type 2 diabetes, who may or may not have metabolic associated fatty liver disease (MASLD).
Why is this trial significant?
This trial is important because it aims to uncover why some people with type 2 diabetes develop fatty liver and heart issues, addressing a gap in understanding these interconnected conditions.
What are the potential risks of participating in NCT07246421?
Risks include discomfort from blood draws, biopsies, and potential side effects from hormone infusions. Some procedures like PET-CT scans involve radiation exposure. There's a small risk of bruising or infection at biopsy sites. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07246421?
Ask your doctor if this study is right for you, especially regarding your diabetes and liver health. Be prepared for multiple visits, including a full day of tests and infusions. You may need to temporarily stop certain diabetes or blood pressure medications on study days. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07246421 signal from an investment perspective?
This early-phase research from a university sponsor focuses on a fundamental biological mechanism, potentially paving the way for future drug development in the large MASLD and T2DM markets. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves 2 short visits and 1 full-day visit with scans, blood tests, and hormone infusions. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.