Metabolic measures 12 months after a randomised controlled trial of treatment of clozapine associated obesity and diabetes with exenatide (CODEX)

What Was Tested

The paper reports a study of Exenatide, published as a randomized controlled trial.

Glucagon-like-peptide-1 (GLP-1) receptor agonists such as exenatide can counter clozapine-associated GLP-1 dysregulation.

The researchers examined whether this effect was maintained at 12-months post-intervention.

Who Took Part

According to the abstract, 24 people were involved.

How the Study Was Run

The design is described as randomized, open-label and pilot.

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

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

It is described as a pilot, a small early test of whether a larger Exenatide study would be practical.

What Was Measured

The researchers followed up CODEX trial participants at 12-months post trial endpoint, collecting information on weight, BMI, waist circumference, blood pressure, fasting glucose, HbA1c, and use of metformin.

The primary outcome of interest was change in weight from trial baseline to 12-months post endpoint and trial endpoint to 12-months post endpoint compared between former exenatide and usual care participants.

PubMed files the paper under topics including Blood Glucose, Clozapine, Diabetes Mellitus, Type 2, Exenatide, Glycated Hemoglobin, Hypoglycemic Agents and Obesity.

Author keywords: GLP-1RA, Metabolic syndrome and Schizophrenia.

What This Means in Plain Language

The paper is a randomized, open-label and pilot study of Exenatide in 24 people.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2020 (Journal of psychiatric research), a journal based in England.

More context: the Exenatide compound page, all human trials.