Cushing DiseasePhase 4NCT03080181
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment
A Phase 4 study testing Pasireotide 0.6 MG/ML in people with Cushing Disease, run by University of Palermo.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Disease
- What is being tested?
- Pasireotide 0.6 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2013to 28 Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with active Cushing's disease.
Who cannot join
- 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.
About this study
Official title: Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
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.
- Conditions
- Cushing Disease
- Being tested
- Pasireotide 0.6 MG/ML
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide 0.6 MG/MLDrug
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 group | Role | What they receive |
|---|---|---|
| pasireotide | Experimental | Pasireotide was administered in a 12 months period Receives: Drug: Pasireotide 0.6 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of circulating adipokines levels
Measured: Change from baseline to 12 months of therapy
Change of homeostasis model assessment (HOMA-β )
Measured: 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
Measured: Change from baseline to 6 and 12 months of therapy
Change of M value evaluated by the euglycemic hyperinsulinemic clamp
Measured: Change from baseline to 12 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startMay 2013
- Primary completion30 Dec 2016
- Study completion28 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Giordano, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080181
- Sponsor's protocol ID
- Pasireotide-CD
- Status last verified
- Oct 2017
- First submitted
- 3 Mar 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
- ClinicalTrials.gov ID
- NCT03080181
- Acronym / sponsor ID
- Pasireotide-CD
- Conditions
- Cushing Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 28 Jan 2017 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pasireotide | Experimental | Drug: Pasireotide 0.6 MG/MLPasireotide was administered in a 12 months period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with active Cushing's disease.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide 0.6 MG/MLThe aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD). | Drug | pasireotide |
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pasireotide 0.6 MG/ML in people with Cushing Disease, run by University of Palermo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of circulating adipokines levels (time frame: Change from baseline to 12 months of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.