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

• Sponsor: University of Palermo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03080181
• Collaborator: (none)
• Enrollment: 24
• Arm: 1
• Actual Duration (Months): 44.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cushing Disease	Drug: Pasireotide 0.6 MG/ML	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
• Actual Study Start Date: May 1, 2013
• Actual Primary Completion Date: Dec 30, 2016
• Actual Study Completion Date: Jan 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pasireotide Pasireotide was administered in a 12 months period	Drug: Pasireotide 0.6 MG/ML; 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).

Outcome Measures

Primary Outcome Measures

1. Change of circulating adipokines levels [Change from baseline to 12 months of therapy]

2. Change of homeostasis model assessment (HOMA-β ) [Change from baseline to 6 and 12 months of therapy]

3. 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]

4. Change of M value evaluated by the euglycemic hyperinsulinemic clamp [Change from baseline to 12 months of therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carla Giordano, Professor, University of Palermo
• ClinicalTrials.gov Identifier: NCT03080181
• Other Study ID Numbers: Pasireotide-CD
• First Posted: Mar 15, 2017
• Last Update Posted: Oct 27, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion; Pasireotide

Study Results

No Results Posted as of Oct 27, 2017