Recruiting

Glucagon

Sponsor:

Mayo Clinic

Code:

NCT06424106

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

Glucagon

Glucose

Study Details

Brief summary:

Fasting hyperglycemia contributes disproportionately to nonenzymatic glycosylation and the microvascular complications of type 2 diabetes. However, little is known about the regulation of glucose concentrations in the fasting state relative to what is known about the postprandial state. The proposed experiment is part of a series of experiments designed to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.

Conditions

PreDiabetes

Study ID

NCT06424106

Start date

Apr 1, 2025

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals with normal or impaired fasting glucose and normal or impaired glucose tolerance

Exclusion Criteria:

  • HbA1c less than 6.5%
  • Use of any glucose-lowering agents including metformin or sulfonylureas.
  • For female subjects: positive pregnancy test at the time of enrollment or study
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Glucagon Infusion

A glucagon infusion (0.2 ng/kg/min) will start at 0900 (0 min), increasing to 0.4 (1000), 0.6 (1100) and 0.8 ng/kg/min (1200) at 60-minute intervals - ending at 1300 (240 min).

placebo comparator: Glucose Infusion

At 0900 (0 min) a glucose infusion will commence, and the infusion rate varied to replicate (± 5mg/dL) that individual's glucose concentrations observed during the Glucagon Infusion Day. The experiment will end at 1300 (240 min) when infusions are stopped.

Interventions

Glucagon

a variable rate glucagon infusion

Glucose

a variable rate glucose infusion

Primary outcome measure

  • Change in beta-cell responsivity induced by glucagon [ Time Frame: Beta-cell responsivity will be calculated as the gradient of the relationship between glucose concentrations and insulin secretion rate during the study day over the 4 hours (0 to 240 minutes) of the study ]

Central Contacts and Locations

Central contacts

Kim Osmundson, CCRP

507-255-0907Osmundson.Kimberly@mayo.edu

Jeanette Laugen

507-255-8110Laugen.Jeanette@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Insulin secretion
  • glucagon secretion
  • endogenous glucose production
  • glucose disappearance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-20.