Clinical Trial: Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: University of Palermo
Current Primary Outcome:
- 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: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Palermo
Dates:
Date Received: March 3, 2017
Date Started: May 2013
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017
