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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06137079
Other study ID # 24/13
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2013
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Azienda Ospedaliero-Universitaria di Modena
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with hemochromatosis or Thalassemia develop progressive tissue and organs damages secondary to iron overload. Iron overload can result both from transfusional hemosiderosis and excess gastrointestinal iron absorption. Iron deposition in the heart, liver, and multiple endocrine glands results in severe damage to these organs, with variable degrees of endocrine and organ failure. Although patients with iron overload often present endocrine disorders, the pathogenetic mechanisms underlying endocrinopathies are not completely clear. In particular it is not elucidated if the spectrum of endocrinopathies could change with advancing age. All endocrinological comorbidities can develop from a primary damage of the target gland, from pituitary secondary failure or from both. The aim of this study is to investigate the prevalence of endocrinological diseases in adult patients with iron overload due to β-thalassemia or hemochromatosis and their impact on well-being and quality of life. The study design is a prospective cross-sectional clinical study. All subjects enrolled will be evaluated for the endocrine diseases. The study protocol will include data collection from family and patients' history of diseases, physical examination, hormonal assessment for all endocrine axes and instrumental examinations. The results will provide evidence on the prevalence of endocrine diseases in patients with iron overload and will add information to characterize the type and the degree of endocrine deficiencies, and on the pathogenic mechanisms involved, in order to individualize diagnostic and therapeutic approaches.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Certain diagnosis of ß-thalassemia major or intermedia - Certain diagnosis of Hereditary Hemochromatosis - Adult patients with an age between 18 and 65 years Exclusion Criteria: - Subjects with an age < 18 and > 65 years

Study Design


Locations

Country Name City State
Italy Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena Modena

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimate prevalence of endocrine comorbidities of ß-thalassemia in adulthood 12 years
Secondary Evaluate prevalence of endocrine diseases to characterize the type and the degree of endocrine deficiencies 12 years
Secondary Evaluate incidence of endocrine diseases to characterize the type and the degree of endocrine deficiencies 12 years
Secondary To investigate the relationships among iron status and endocrine alterations in these group of patients 12 years
Secondary To investigate the relationships among iron status and cardiac disease in these group of patients 12 years
Secondary To investigate the relationships among iron status and liver disease in these group of patients 12 years
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