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).
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
Status
Completed
Phase
Phase 4
Enrollment
24
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 15, 2017
Study start
May 2013
Primary completion
Dec 30, 2016
Study completion
Jan 28, 2017
Results posted
Not reported
Registry updated
Oct 27, 2017
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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