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

NCT ID: NCT03080181

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-01-28

Brief Summary

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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

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Conditions

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Cushing Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pasireotide

Pasireotide was administered in a 12 months period

Group Type EXPERIMENTAL

Pasireotide 0.6 MG/ML

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Carla Giordano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Pasireotide-CD

Identifier Type: -

Identifier Source: org_study_id