Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Apelin.

The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998).

The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.

Recent work by the team of Prof.

It had two arms (groups): Apelin (experimental) and Placebo (placebo comparator).

An apelin clamp in which an apelin infusion will be administered prior to reference clamp.

A clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: Men aged 18 to 40 years. BMI between 25 and 30 kg / cm ² (excluding terminals). Free of known chronic disease and any medication (any medication within 30 days prior to the inclusion visit). Heart rate between 50 and 80 beats per minute rest. Good peripheral vein (forearm and back of the hand).

The full record lists 16 inclusion and 13 exclusion criteria; among the exclusions: repeated a qtc interval\> 450 ms measurement; risk factor: myocardial infarction, hypokalemia, family history of long qt syndrome; personal history of cancer.

How the Study Was Run

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

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

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

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

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

It started in 2014-01 with completion listed for 2014-10.

It ran at 1 site in France.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Rate of glucose infusion (time frame: The last 30 minutes of a hyperinsulinemic euglycemic clamp).

It also tracked 11 secondary outcomes, for example Calculation of the index of insulin sensitivity (Si), Changes in the measurement of systolic blood pressure during each clamp, Changes in the measurement of diastolic blood pressure during each clamp, Changes in heart rate measurement during each clamp, Changes in ECG during each clamp and Clinical signs of intolerance / allergy / toxicity at visit 2,3 and 4.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Apelin in 16 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 Apelin compound page, all human trials.