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

University of Palermo

Status and phase: Completed; Phase 4

Conditions: Cushing Disease

Treatments: Drug: Pasireotide 0.6 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03080181

Pasireotide-CD

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

pasireotide

Experimental group

Description:

Pasireotide was administered in a 12 months period

Treatment:

Drug: Pasireotide 0.6 MG/ML