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The Effects of Glucagon on Hepatic Metabolism Phase 1, Phase 2 21

Active, not recruiting
Clinical Trial NCT05500586 is designed to study Basic Science for Obesity, Type2diabetes, NAFLD. It is a Phase 1 Phase 2 interventional study that is active, not recruiting, having started on October 20, 2022, with plans to enroll 21 participants. Led by Adrian Vella, it is expected to complete by March 31, 2026. The latest data from ClinicalTrials.gov was last updated on March 5, 2026.
Brief Summary
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 ...Show More
Detailed Description
T2DM and prediabetes are characterized by abnormal post-prandial suppression of glucagon, which contributes to postprandial hyperglycemia by increasing EGP. Although these effects are magnified by decreased and delayed insulin secretion, they are also apparent when insulin secretion is intact. In rodents, altered glucagon signaling changes α-cell function and mass - an effect mediated by changes in circulating AA con...Show More
Official Title

The Effects of Glucagon on Hepatic Metabolism

Conditions
ObesityType2diabetesNAFLD
Other Study IDs
  • 22-000113
NCT ID Number
NCT05500586
Start Date (Actual)
2022-10-20
Last Update Posted
2026-03-05
Completion Date (Estimated)
2026-03-31
Enrollment (Estimated)
21
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Active, not recruiting
Keywords
glucagon
insulin resistance
hepatic steatosis
amino acid metabolism
Primary Purpose
Basic Science
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHealthy Adults
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Glucagon response study
Please see information in group descriptions
ExperimentalObese Adults
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Glucagon response study
Please see information in group descriptions
ExperimentalAdults with Type 2 Diabetes
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Glucagon response study
Please see information in group descriptions
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rate of Amino acid catabolism in the presence / absence of glucagon
Tracer-dependent measurement of amino-acid clearance
240 minutes of study
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Effect of Diabetes on amino-acid catabolism
Tracer-dependent measurement of amino-acid clearance
240 minutes of study
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Willing to participate
  • Able to give consent

  • History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g. metal implants, claustrophobia).
  • Hematocrit < 35%
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire
Adrian Vella logoAdrian Vella
Study Responsible Party
Adrian Vella, Sponsor-Investigator, Regulatory Sponsor, Mayo Clinic
No contact data.
1 Study Locations in 1 Countries

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States