Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia

May 10, 2024 updated by: Demiana Adel Aziz, Assiut University
to evaluate thyroid function ,HbA1C,&lipid profile in thalassemic patient to correlate thyroid function , Hba1c , lipid profile e ferritin level in thalassemic patient

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

B-Thalassemia major (b-TM) is a hereditary ،anemia resulting from defects in the production of b-globin chains and is one of the most common genetic disorders worldwide.

The clinical classification of thalassemias is currently widely applied in clinical practice related to transfusion requirements Transfusion-dependent thalassemia (TDT) is defined as a condition where patients cannot produce adequate hemoglobin to survive without blood transfusion. Non-transfusion-dependent thalassemia (NTDT) is a descriptive term for patients who do not require regular lifelong transfusions. They may require intermittent or frequent transfusions in certain clinical situations.

Patients with β-thalassemia intermedia have symptoms in between carriers and those with β-thalassemia major.

Endocrine complications are the commonest among BTM patients and the attributing factor is iron deposition in endocrine organs due to frequent blood transfusions along with suboptimal iron chelation. Thus, keeping an iron level within the useful and safe range is critical since a low amount can cause anemia, while a high level can cause tissue damage Background pathophysiologic mechanism leading to DM in TM is unclear; some regard the iron induced pancreas cytotoxicity as the most significant contributor, a new hypothesis suggests the exhaustion of beta pancreatic cells subsequent to a chronic period of hyperinsulinemia .There are 5% of thalassemia patients develop clinical hypothyroidism that requires treatment, a bigger number of them develop subclinical compensated hypothyroidism with normal T3 and T4 levels but high TSH serum levels.

The TDT is also associated with altered lipid levels because of oxidative stress that can lead to early atherosclerosis, adding to the morbidity and even early mortality.

Study Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patient aged18 and older ,both gender. patient diagnosed B thalassemia major &intermediate

Description

Inclusion Criteria:

  • patient aged18 and older
  • both gender
  • patient diagnosed B thalassemia major
  • patient diagnosed B thalassemia intermediate

Exclusion Criteria:

  • thalaasemia trait
  • age less than 18
  • type 1 D.M
  • pt known thyroid &recive tttt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Beta thalassemia ( major)
2
Beta thalassemia (intermediate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia
Time Frame: 24 month
HbA1c in thalassemia major versus intermediate
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mostafa Haridy, Prof, yes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • endocrine dis & B thalassemia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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