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CompletedNCT03080181Updated Oct 27, 2017

Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment

A Phase 4 interventional study of Pasireotide 0.6 MG/ML in Cushing Disease, sponsored by University of Palermo. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by University of Palermo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with active Cushing's disease.

Exclusion criteria

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    pasireotide

    Pasireotide was administered in a 12 months period

    Drug: Pasireotide 0.6 MG/ML

Interventions

  • DrugPasireotide 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).

05

What researchers measure

Primary outcomes

  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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03080181
Lead sponsor
University of Palermo
Responsible party
Carla Giordano (Professor, University of Palermo) — Principal investigator
First posted
Mar 15, 2017
Start date
May 2013
Primary completion
Dec 30, 2016
Completion
Jan 28, 2017
Last update
Oct 27, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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