"Iron Overload and Endocrinological Diseases"

Iron Overload Clinical Trial

Official title:

"Iron Overload and Endocrinological Diseases"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137079
• Other study ID #: 24/13
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• beta-Thalassemia
• Endocrinopathy
• Hemochromatosis
• Hemosiderosis
• Iron Overload
• Thalassemia
• Thalassemia Intermedia
• Thalassemia Major

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