|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03080181 |
|
Date of registration:
|
03/03/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
|
|
Scientific title:
|
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters |
|
Date of first enrolment:
|
May 2013 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03080181 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cushing Disease
|
|
Intervention(s)
|
|
Drug: Pasireotide 0.6 MG/ML
|
|
Primary Outcome(s)
|
|
Change of circulating adipokines levels
[Time Frame: Change from baseline to 12 months of therapy]
|
|
Change of homeostasis model assessment (HOMA-ß )
[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 ID(s)
|
|
Pasireotide-CD
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|