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

Phase 4

Completed

• Conditions: Cushing Disease
• Interventions: Drug: Pasireotide 0.6 MG/ML

• Registration Number: NCT03080181
• Lead Sponsor: University of Palermo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2016-12-30
• Study Completion: 2017-01-28
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pasireotide	Pasireotide 0.6 MG/ML	Pasireotide was administered in a 12 months period

Primary Outcome Measures

Name	Time	Method
Change of circulating adipokines levels	Change from baseline to 12 months of therapy
Change of homeostasis model assessment (HOMA-β )	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	Change from baseline to 6 and 12 months of therapy
Change of M value evaluated by the euglycemic hyperinsulinemic clamp	Change from baseline to 12 months of therapy