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

University of Palermo24 enrolled

Overview

Background: Pasireotide treatment is strictly associated with glucose metabolism impairment. 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. Circulating adipokines were evaluated in patients with CD compared to a matched group of 12 diabetic patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cushing Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with active Cushing's disease. Exclusion Criteria: * pituitary radiotherapy treatment performed less than 5 years before pasireotide, * pregnancy, * women taking oral contraceptives, * diabetes on GLP-1 analogues, * DPP4 inhibitors or sulphonylureas treatment, * intolerance to SSA, * risk conditions for prolonged QT syndrome and severe liver o renal insufficiency.

Outcomes

Primary Outcomes

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

Change of M value evaluated by the euglycemic hyperinsulinemic clamp

Time frame: Change from baseline to 12 months of therapy