Effects of Glucagon Administration on Energy Expenditure

What Was Tested

This registered phase 1 trial tested Insulin (regular human) and Glucagon.

It had three arms (groups): Glucagon with Octreotide and insulin (active comparator), Placebo, Glucagon with Octreotide and Insulin (placebo comparator) and Placebo, with Octreotide and insulin (placebo comparator).

Overnight (10 hours) infusion of glucagon, then 3 hours infusion of glucagon with concurrent infusions of Octreotide and insulin.

Overnight (10 hours) infusion of saline, then 3 hour infusion of glucagon with concurrent infusions of Octreotide and insulin.

Overnight (10 hours) infusion of saline, then 3 hour infusion of saline with concurrent infusions of Octreotide and insulin.

The registry classes the interventions as behavioral and drug.

More on the Plan

To determine the effects of prolonged hyperglucagonemia to acute hyperglucagonemia on rates of substrate oxidation, fibroblast growth factor21 and metabolites of interest.

Who Took Part

6 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Subject is a male between the ages of 18 and 50 years. Subject has been weight stable over the last 3 months (plus or minus 3 kg). Subject is judged to be non-diabetic and in good health on the basis of medical history, physical examination, electrocardiogram, and routine laboratory data. Subject understands the procedures and agrees to participate in the study program by giving written informed consent, and is willing to comply with the trial restrictions. Subject is willing to avoid alcohol consumption for 48 hours prior to each period.

The full record lists 8 inclusion and 25 exclusion criteria; among the exclusions: has a known history of any endocrine tumors (e.g. pheochromocytoma, glucagonoma, or insulinoma, etc.); has impaired kidney or liver function, as evidenced by screening blood work; has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, constipation or abdominal pain.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2014-09 with completion listed for 2015-06.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Measure of energy expenditure (time frame: Day 2, Day 9, Day 16).

It also tracked 1 secondary outcome, for example Measure of endogenous glucose production.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Glucagon in 6 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 Insulin (regular human) compound page and the Glucagon compound page, all human trials.