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

Primary Purpose

Cushing Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pasireotide 0.6 MG/ML
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pasireotide

    Arm Description

    Pasireotide was administered in a 12 months period

    Outcomes

    Primary Outcome Measures

    Change of circulating adipokines levels
    Change of homeostasis model assessment (HOMA-β )
    Change of area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test
    Change of M value evaluated by the euglycemic hyperinsulinemic clamp

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2017
    Last Updated
    October 25, 2017
    Sponsor
    University of Palermo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03080181
    Brief Title
    Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
    Official Title
    Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (Actual)
    Primary Completion Date
    December 30, 2016 (Actual)
    Study Completion Date
    January 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Palermo

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cushing Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pasireotide
    Arm Type
    Experimental
    Arm Description
    Pasireotide was administered in a 12 months period
    Intervention Type
    Drug
    Intervention Name(s)
    Pasireotide 0.6 MG/ML
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change of circulating adipokines levels
    Time Frame
    Change from baseline to 12 months of therapy
    Title
    Change of homeostasis model assessment (HOMA-β )
    Time Frame
    Change from baseline to 6 and 12 months of therapy
    Title
    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
    Title
    Change of M value evaluated by the euglycemic hyperinsulinemic clamp
    Time Frame
    Change from baseline to 12 months of therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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