An observational study in Iron Overload, Thalassemia Major and Thalassemia Intermedia, sponsored by Azienda Ospedaliero-Universitaria di Modena. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Azienda Ospedaliero-Universitaria di Modena · Observational
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.
55 studies on the registry are indexed under Hemochromatosis; 4 are open to participants now.
This study's planned enrollment of 62 is below the median of 70 across 19 observational studies indexed under Hemochromatosis.
Browse Hemochromatosis studies →Azienda Ospedaliero-Universitaria di Modena is the lead sponsor of 48 studies on the registry; 20 are open to participants now.
Compared within Hemochromatosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Iron Overload. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult patients with a confirmed diagnosis of β-thalassemia (major or intermedia) or with a diagnosis of hemochromatosis enrolled at the "Unit of Endocrinology, Department of Medical Specialties, Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena, Ospedale Civile di Baggiovara, Modena, Italy".
Since thalassemia is a rare pathology and considering that the involvement of the endocrine glands in thalassemic patients is extremely common (it is expected to find at least one impaired endocrinological axis in each patient), the number of patients the investigators will enroll is appropriate to make an estimation of the prevalence of endocrine deficiency. Patients will be considered eligible according to the inclusion and exclusion criteria, independently from the presence/absence of known endocrine diseases and after providing their informed signed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Estimate prevalence of endocrine comorbidities of β-thalassemia in adulthood
Time frame: 12 years
Evaluate prevalence of endocrine diseases to characterize the type and the degree of endocrine deficiencies
Time frame: 12 years
Evaluate incidence of endocrine diseases to characterize the type and the degree of endocrine deficiencies
Time frame: 12 years
To investigate the relationships among iron status and endocrine alterations in these group of patients
Time frame: 12 years
To investigate the relationships among iron status and cardiac disease in these group of patients
Time frame: 12 years
To investigate the relationships among iron status and liver disease in these group of patients
Time frame: 12 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Azienda Ospedaliero-Universitaria di Modena