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Effect of Physiologic Hyperglucogonemia on Adipocyte Metabolism

Plain-language guide to NCT04300049: early phase 1 interventional trial of Glucagon, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04300049
Phase
early phase 1
Status
completed
Start
2018-02-05
Completion (planned or actual)
2023-11-15
Participants
10 (actual)
Design
na, open label (everyone knows who gets what), basic_science
Conditions studied
Insulin Sensitivity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this early phase 1 trial, researchers set out to test Glucagon.

Purpose/Objectives: To investigate the effect of hyperglucagonemia on insulin action, particularly on adipose tissue.

Study subjects will receive a continuous glucagon infusion for 12 hours.

It had 1 arm (groups): Change in Glycerol Ra (experimental).

The difference in rate of lipolysis (glycerol Ra) during the basal state (-120 -0 minute) between subjects receiving glucagon and saline represents the change in whole body lipolysis caused by glucagon.

The registry classes the interventions as drug and other.

More on the Plan

Visit 1 Screening: All subjects will be performed indirect calorimetry to determine rates of energy expenditure and glucose/lipid oxidation for 40 minutes prior to all other procedures to obtain a fasting calorimetry.

Blood will be drawn at -30, -15, 0 and at 15, 30, 45, 60, 90 and 120 minutes thereafter for the determination of plasma glucose, insulin, C-peptide, glucagon, FFA, glycerol, GLP-1 and GIP concentrations.

Participants will also undergo a total body fat (DXA) and hepatic fat content (MRS).

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Weight Stable (±3 lbs) over the preceding 3 months. Ages from 18-50. BMI from 23-28 kg/m2 -.

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: subjects who participate in an excessively heavy exercise program; subjects taking any medication known to affect glucose tolerance will be excluded; cannot be pregnant.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Glucagon study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-02-05 with completion listed for 2023-11-15.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: the rate of glycerol turnover (time frame: 12 hours after the infusion).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Glucagon in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.

Our Notes on the Compound

Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.