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The Underlying Mechanisms Regarding the Effect of Glucagon on the Kidneys Will be Investigated in Healthy Males.

Plain-language guide to NCT06498063: not phased randomized trial of Glucagon, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06498063
Phase
not phased
Status
status unknown
Start
2024-02-20
Completion (planned or actual)
2025-03-28
Participants
10 (estimated)
Design
randomized, triple-blind, basic_science
Conditions studied
Kidney Diseases
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Glucagon.

The goal of this crossover study is to investigate to what extend glucagon affects the kidneys.

The main questions it aims to answer are: Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration?

It had three arms (groups): Glucagon (experimental), Glucagon+Exendin9-39 (experimental) and Sodium chloride (Placebo comparator) (placebo comparator).

Glucagon infusion of 5 ng·kg-1·min-1 from 0-60 minutes and 10 ng·kg-1 ·min-1 from 60-120 minutes.

The registry classes the interventions as other.

More on the Plan

In patients with type 2 diabetes mellitus, plasma concentrations of glucagon are inappropriately high (hyperglucagonemia).

Hyperglucagonemia has been speculated to contribute to the pathophysiology of diabetic kidney disease.

The purpose of this study is to clarify the underlying mechanisms behind the physiological effects of glucagon on kidney function and the kidney's ability to clear glucagon from the blood in healthy males.

Specifically, the investigators aim to answer the following questions: Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration?

Who Took Part

10 planned participants were the target.

It was open to men only aged from 20 years up to 60 years.

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

Examples of who could join: Age: 20-60 years. Normal health ascertained through questioning and medical examination. Normal values for blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, HDL, LDL, creatinine, liver function, and electrolytes.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: immunosuppressive treatment in the preceding 12 months; alcohol abuse; medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (dpp-4) inhibitors, or glp-1 receptor agonists, which, in the opinion of the investigator, may interfere with glucose metabolism.

How the Study Was Run

Design: randomized, crossover and triple-blind.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2024-02-20 with completion listed for 2025-03-28.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Natriuresis (time frame: Analyzed from urine samples at -60, 0, 60 and 120 minutes). Glucagon extraction (time frame: Analyzed from blood samples drawn at -30, 0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 minutes).

It also tracked 4 secondary outcomes, for example Glomerular filtration rate, Diuresis, Renal Blood Flow and Urea.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 10 people.

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

Its status is unknown; 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.