Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance

What Was Tested

This registered not phased trial tested Glucagon.

It had four arms (groups): Healthy, lean subjects (experimental), Healthy, obese subjects (experimental), Diabetic, lean subjects (experimental) and Diabetic, obese subjects (experimental).

Healthy subjects with BMI \< 27 kg/m\^2.

Healthy subjects with BMI \> 33 kg/m\^2.

Diabetic subjects with BMI \< 27 kg/m\^2.

The registry classes the interventions as biological.

More on the Plan

Furthermore, the investigators wish to examine whether obesity is an independent factor for altered glucagon metabolism.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: BMI either below 27 or above 33 kg/m\^2. Caucasians above 35 years of age. BMI either below 27 or above 33 kg/m\^2. Normal HbA1c (according to WHO criteria).

The full record lists 9 inclusion and 16 exclusion criteria; among the exclusions: inflammatory bowel disease; operation within the last 3 months; severe liver disease (serum alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) \>2×normal values).

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Glucagon group and the comparison group ran side by side rather than switching.

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

It started in 2015-05 with completion listed for 2016-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Metabolic clearance rate of glucagon (time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes).

It also tracked 6 secondary outcomes, for example Gut and pancreatic hormones, Blood glucose, Basic metabolic rate, Satiety, hunger, appetite - measured with visual analogue scales (VAS), Half life of glucagon and The volume of distribution of glucagon.

What This Means in Plain Language

Put simply, this is a not phased, non-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.