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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

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.


Condition or disease Intervention/treatment Phase
Cushing Disease Drug: Pasireotide 0.6 MG/ML Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
Actual Study Start Date : May 2013
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : January 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Arm Intervention/treatment
Experimental: pasireotide
Pasireotide was administered in a 12 months period
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).




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Carla Giordano, Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT03080181     History of Changes
Other Study ID Numbers: Pasireotide-CD
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs