Studies of Insulin and Glucagon Action in the Liver

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07300982
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diabetes (DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Glucagon — DRUG
    Glucagon infusion either graded (0.2→0.4→0.6 ng/kg/min) or continuous (0.4 ng/kg/min) during the final 90 minutes of a hyperinsulinemic glucose clamp. The graded or continuous glucagon infusions are given as a component of 2 separate protocols. Glucagon prepared per pharmacy/bedside protocol.
  • Saline (placebo) — DRUG
    IV saline infusion during clamp for 90 minutes as control.

Study Details

This study examines how glucagon works to regulate glucose metabolism, based on new findings that suggest glucagon signaling in the liver has more than one role, and that these multiple roles can be opposing in nature. Understanding this biology provides an opportunity to develop new generations of glucagon-based drugs that target specific pathways, making them more effective at controlling blood glucose. Participants will complete paired, 5-hour hyperinsulinemic glucose clamp visits in which they receive either glucagon or saline infusions while blood glucose is maintained and frequent blood samples are collected. The primary focus is whether coordinated glucagon and insulin signaling enhances hepatic insulin sensitivity.

Key Dates

Start date
Apr 30, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Glucagon infusion during hyperinsulinemic clamp
    Glucagon infusion either graded (0.2→0.4→0.6 ng/kg/min) or continuous (0.4 ng/kg/min) during the final 90 minutes of a hyperinsulinemic glucose clamp. The graded or continuous glucagon infusions are given as a component of 2 separate protocols.
  • Placebo Comparator: Saline infusion during hyperinsulinemic clamp
    Saline infusion during the final 90 minutes of an otherwise identical clamp procedure.

Primary Outcome Measure

Glucose appearance (Ra) [ Time Frame: In these experiments outcomes will be based on measurements made in the final 90 minutes of the hyperinsulinemic glucose clamp. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Center for LivingDurhamNorth Carolina27705
Johanna Johnson, MS
[email protected]
919-660-6766
Alyssa Sudnick, MS
[email protected]
919-660-6769
David D'Alessio, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke Center for Living· Durham, NC

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