Recruiting

Insulin

Sponsor:

Mayo Clinic

Code:

NCT06424015

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

Intralipid and heparin

Saline

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

NCT06424015

Start date

Sep 15, 2024

Status verified date

Sep, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. HbA1c > 6.5%
2. BMI ≥ 35 Kg/M2
3. Use of any glucose-lowering agents including metformin or sulfonylureas.
4. For female subjects: positive pregnancy test at the time of enrollment or study
5. History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
6. Active systemic illness or malignancy.
7. Symptomatic macrovascular or microvascular disease.
8. Hematocrit < 35%

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Intralipid and heparin

Between 0600 (-180 min) and 1300 (240 min) Intralipid (20%, 0.011ml/kg/min; Baxter, Healthcare, Deerfield, IL) and heparin (200 units prime, 0.2 unit/kg/min continuous) will be infused to induce acute insulin resistance.

placebo comparator: Saline

Between 0600 (-180 min) and 1300 (240 min) saline will be infused

Interventions

Intralipid and heparin

Intralipid (20%, 0.011ml/kg/min; Baxter, Healthcare, Deerfield, IL) and heparin (200 units prime, 0.2 unit/kg/min continuous) will be infused to induce acute insulin resistance

Saline

Saline will be infused

Primary outcome measure

  • Suppression of Endogenous glucose production (EGP) by insulin [ Time Frame: The rate of EGP at 240 minutes (end of study) expressed as a percentage of fasting EGP (at the start of the study i.e.: 0 minutes. ]
  • Insulin pulse orderliness [ Time Frame: Approximate Entropy (ApEn) will be calculated from the insulin concentrations observed every 2 minutes between -45 and 0 minutes ]

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

Oct 1, 2025

Last verified

Sep, 2025

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 2025-10-01.