Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment

What Was Tested

In this phase 4 trial, researchers set out to test Pasireotide.

The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD).

Methods: Clinical and hormonal parameters, insulin secretion, evaluated by homostasis model assessment (HOMA-β) and by the area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test and insulin sensitivity, evaluated by the euglycemic hyperinsulinemic clamp, were evaluated in 12 patients with active CD before and after 12 months of pasireotide.

It had 1 arm (groups): pasireotide (experimental).

Pasireotide was administered in a 12 months period.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with active Cushing's disease.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: pituitary radiotherapy treatment performed less than 5 years before pasireotide,; women taking oral contraceptives,; diabetes on glp-1 analogues,.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-05 with completion listed for 2016-12-30.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change of circulating adipokines levels (time frame: Change from baseline to 12 months of therapy). Change of homeostasis model assessment (HOMA-β ) (time frame: Change from baseline to 6 and 12 months of therapy). Change of area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test (time frame: Change from baseline to 6 and 12 months of therapy).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Pasireotide in 24 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 Pasireotide compound page, all human trials.