Insulin and Insulin Pulses During Fasting

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06424015
Status
Recruiting
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Conditions

  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Intralipid and heparin — OTHER
    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 — OTHER
    Saline will be infused

Study Details

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.

Key Dates

Start date
Sep 15, 2024
Status verified
Sep 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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Mayo Clinic in Rochester· Rochester, MN

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