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

Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03080181

Enrollment

Registered

2017-03-15

Start date

2013-05-31

Completion date

2017-01-28

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing Disease

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.

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change of circulating adipokines levels	Change from baseline to 12 months of therapy
Change of homeostasis model assessment (HOMA-β )	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	Change from baseline to 6 and 12 months of therapy
Change of M value evaluated by the euglycemic hyperinsulinemic clamp	Change from baseline to 12 months of therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026