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Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge

Plain-language guide to NCT03061227: not phased randomized trial of Glucagon, 32 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03061227
Phase
not phased
Status
completed
Start
2017-02-10
Completion (planned or actual)
2019-01-17
Participants
32 (actual)
Design
randomized, single-blind, basic_science
Conditions studied
Metabolic Syndrome; Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Glucagon.

The investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load.

It had two arms (groups): Intravenous glucagon (active comparator) and Intravenous saline (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: BMI 18.5- 29.9 kg/m2. Written informed consent.

The full record lists 2 inclusion and 26 exclusion criteria; among the exclusions: febrile infection with temperatures\> 38.5 ° c in the last 14 days; blood donation within the last 12 weeks pre-study inclusion; chronic diseases:.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

In this single-blind Glucagon study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-02-10 with completion listed for 2019-01-17.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Brain activity (time frame: change from baseline to 120 minutes after oral glucose challenge).

It also tracked 6 secondary outcomes, for example Hunger rating, Brain response to food cues, Glucose tolerance, Insulin sensitivity, Basal energy expenditure and Change in hormone levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 32 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.