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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03080181 (opens ClinicalTrials.gov in a new tab)Other idPasireotide-CD
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Overview

Status
Completed
Phase
Phase 4
Enrollment
24 participants (actual)
Sponsor
University of Palermo · Other
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
May 2013
Primary completion
30 Dec 2016
Completion
28 Jan 2017
First posted
15 Mar 2017
Last update posted
27 Oct 2017
Conditions
Cushing Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015201620172018
  1. Ph 4

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

    NCT03080181

    May 2013 to 28 Jan 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Pasireotide 0.6 MG/MLDrug

Arms1

  • Experimental

    pasireotide

    Pasireotide was administered in a 12 months period

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Change of circulating adipokines levels

    Time frame · Change from baseline to 12 months of therapy

  2. Change of homeostasis model assessment (HOMA-β )

    Time frame · 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

    Time frame · Change from baseline to 6 and 12 months of therapy

  4. Change of M value evaluated by the euglycemic hyperinsulinemic clamp

    Time frame · Change from baseline to 12 months of therapy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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