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Not yet recruiting NCT07300982

Studies of Insulin and Glucagon Action in the Liver

Phase I / Phase II Interventional Diabetes (DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glucagon, Saline (placebo).
Who it may be relevant to
Registry conditions: Diabetes (DM). Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Volunteers will undergo screening for medical history, medication usage, and blood work; those who qualify will be offered participation. Study participation will last approximately 5-12 weeks depending on appointment availability and the number of infusions planned. This protocol involves two sets of paired procedures. Approximately 15 participants will complete each set of paired visits. Participants can opt to complete one set of paired visits or both sets of paired visits.

Set 1: Each participant will complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of glucagon on glucose metabolism while measuring systemic glucose turnover and related blood markers. The procedures will be identical, except for the final phase of the procedure when either saline or a stepwise glucagon infusion will be administered.

Set 2: Each participant will complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of insulin on glucose metabolism while measuring systemic glucose turnover and related blood markers. The procedures will be identical, except for the final phase of the procedure when either saline or a steady glucagon infusion will be administered.

Interventions

  • Drug Glucagon
    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.
  • Drug Saline (placebo)
    IV saline infusion during clamp for 90 minutes as control.

Primary outcome measures

  • 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.]
  • Glucose disappearance (Rd) [Time frame: In the experiments described here glucose turnover (Ra and Rd) will be determined in the final 90 minutes of the hyperinsulinemic glucose clamp.]
  • Hepatic insulin sensitivity [Time frame: Basal period (time -30-0 min), after the insulin infusion alone (60-90 min), and during the glucagon/saline infusions (120-180 min)]

Eligibility criteria

Inclusion criteria

  • Healthy adults age 18-45 years
  • Body Mass Index (BMI) < 27.0 kg/m²
  • Fasting plasma glucose ≤ 95 mg/dL or HbA1c ≤ 5.8% as measured at screening visit

Exclusion criteria

  • Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders
  • No personal history of diabetes or pancreatitis
  • No personal history of cardiac, gastrointestinal, renal or liver disease
  • No history of diabetes among any first-degree family members
  • Renal insufficiency (eGFR < 60 mL/kg/min)
  • Anemia (hematocrit < 34%) as measured at screening visit
  • Pregnant females
  • Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Duke Center for Living — Durham

Identifiers

NCT: NCT07300982 · Pro00117291 · R01DK141090

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗