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Completed

NCT Number: NCT03080181

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

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.

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Key information

Conditions

Cushing Disease Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pasireotide 0.6 MG/ML

Drug

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).

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

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Mar 15, 2017
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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