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

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ClinicalTrials.gov Identifier: NCT03080181
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Carla Giordano, University of Palermo

Tracking Information
First Submitted Date  ICMJE March 3, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date October 27, 2017
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • Change of circulating adipokines levels [ Time Frame: Change from baseline to 12 months of therapy ]
  • Change of homeostasis model assessment (HOMA-β ) [ Time Frame: 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 [ Time Frame: Change from baseline to 6 and 12 months of therapy ]
  • Change of M value evaluated by the euglycemic hyperinsulinemic clamp [ Time Frame: Change from baseline to 12 months of therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03080181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
Official Title  ICMJE Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cushing Disease
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: pasireotide
Pasireotide was administered in a 12 months period
Intervention: Drug: Pasireotide 0.6 MG/ML
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2017)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 28, 2017
Actual Primary Completion Date December 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03080181
Other Study ID Numbers  ICMJE Pasireotide-CD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carla Giordano, University of Palermo
Study Sponsor  ICMJE University of Palermo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Palermo
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP