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

NCT03080181 | Completed Phase 4

• 1 other identifier: Pasireotide-CD
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cushing Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

pasireotide

EXPERIMENTAL

Pasireotide was administered in a 12 months period

Drug: Pasireotide 0.6 MG/ML

Interventions

Pasireotide 0.6 MG/ML DRUG

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).

pasireotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with active Cushing's disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Palermo: lead

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 15, 2017
• Study Start: May 1, 2013
• Primary Completion: December 30, 2016
• Study Completion: January 28, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share