NCT05500586CompletedPhase 1/2
The Effects of Glucagon on Hepatic Metabolism
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
Whether impaired postprandial glucagon suppression in prediabetes and T2DM is an attempt to overcome resistance to glucagon's actions on hepatic AA catabolism, a defect in α-cell function, or a combination of both are important, unanswered questions. NAFLD is associated with T2DM risk and impaired insulin action. Unfortunately, it is unclear if glucagon resistance is caused by obesity, hepatic steatosis or both. The experiments outlined will determine if glucagon's actions on hepatic amino acid catabolism and EGP interact with hepatic lipid metabolism in lean and obese subjects with and without T2DM (and with varying degrees of hepatic steatosis).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 10 Aug 2022
- Start date
- 20 Oct 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Adrian Vella
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05500586
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 21
- From 20 Oct 2022 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Subjects with treatment change or significant weight change (≥ 10%) in the prior 3 months.
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
Other illness
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- History of uncontrolled thyroid disease
- Allergy to iodine
- Thrombocytopenia, history of bleeding disorder or use of anticoagulation
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- History of uncontrolled thyroid disease.
- Allergy to iodine
- Thrombocytopenia, history of bleeding disorder or use of anticoagulation
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- History of uncontrolled thyroid disease.
- Allergy to iodine
- Thrombocytopenia, history of bleeding disorder or use of anticoagulation
Lab values
- HbA1c ≥ 8.5%
- HbA1c ≥ 6.5%
- Use of any glucose-lowering agents
- HbA1c ≥ 6.5%
- Use of any glucose-lowering agents
Age
- Age \< 25 or \> 65 years
- Age \< 25 or \> 65 years (match subjects with T2DM)
- Age \< 25 or \> 65 years (match subjects with T2DM)
Other
- BMI ≤ 28 Kg/M2
- For female subjects: positive pregnancy test at the time of enrollment or study
- Known contraindications to MRI
- Hematocrit \< 35%
- Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire.
- BMI ≤ 28 Kg/M2
- For female subjects: positive pregnancy test at the time of enrollment or study
- Known contraindications to MRI
- Hematocrit \< 35%
- Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire.
- BMI ≥ 25 Kg/M2 unless % body fat is \< 20% in males and \< 30% in females.
- For female subjects: positive pregnancy test at the time of enrollment or study
- Known contraindications to MRI
- Hematocrit \< 35%
- Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire.
- Liver fat content ≥ 5% as determined by MRI using the proton density fat fraction (PDFF) technique.
Who the study is looking for
- Type 2 diabetes
- BMI ≥ 28 Kg/M2
- Managed by diet alone or a combination of metformin and/or sulfonylurea
- Willing to stop glucose-lowering medication for 3 weeks prior to participation and willing to self-monitor their fasting glucose during this time
- No history of micro- or macrovascular complications of T2DM
- -Obese subjects without type 2 diabetes but are age, sex and weight-matched (BMI ≥ 28 Kg/M2) with subjects who have T2DM
- -Subjects who do not have type 2 diabetes but are age and sex but are not weight-matched (BMI ≤ 25 Kg/M2) with subjects who have T2DM
Age in the registry: 25 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.