"Iron Overload and Endocrinological Diseases"

Recruiting

• Conditions: Hemochromatosis; Iron Overload; Thalassemia Intermedia; Endocrinopathy; Thalassemia Major

• Registration Number: NCT06137079
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Modena

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-20
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Certain diagnosis of β-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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate prevalence of endocrine comorbidities of β-thalassemia in adulthood	12 years

Secondary Outcome Measures

Name	Time	Method
To investigate the relationships among iron status and cardiac disease in these group of patients	12 years
To investigate the relationships among iron status and liver disease in these group of patients	12 years
To investigate the relationships among iron status and endocrine alterations in these group of patients	12 years
Evaluate prevalence of endocrine diseases to characterize the type and the degree of endocrine deficiencies	12 years
Evaluate incidence of endocrine diseases to characterize the type and the degree of endocrine deficiencies	12 years

Trial Locations

Locations (1)

Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena; 🇮🇹 Modena, Italy