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

Cushing Disease Clinical Trial

Official title:

Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080181
• Other study ID #: Pasireotide-CD
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2017
• Last updated: October 25, 2017
• Start date: May 2013
• Est. completion date: January 28, 2017

Study information

• Verified date: October 2017
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 28, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Cushing Disease
• Pituitary ACTH Hypersecretion

Intervention

Drug:
• Pasireotide 0.6 MG/ML
The aim of the study was to evaluate the effect of pasireotide on ß -cell and adipose function in patients with Cushing's disease (CD).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of circulating adipokines levels		Change from baseline to 12 months of therapy
Primary	Change of homeostasis model assessment (HOMA-ß )		Change from baseline to 6 and 12 months of therapy
Primary	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
Primary	Change of M value evaluated by the euglycemic hyperinsulinemic clamp		Change from baseline to 12 months of therapy