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

B Thalassemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377865
• Other study ID #: endocrine dis & B thalassemia
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: demiana AD aziz, researcher
• Phone: 01551633796
• Email: nanaa3964[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

to evaluate thyroid function ,HbA1C,&lipid profile in thalassemic patient to correlate thyroid function , Hba1c , lipid profile e ferritin level in thalassemic patient

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: May 1, 2026
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• B Thalassemia
• beta-Thalassemia
• Thalassemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Chatterjee R, Bajoria R. New concept in natural history and management of diabetes mellitus in thalassemia major. Hemoglobin. 2009;33 Suppl 1:S127-30. doi: 10.3109/09553000903347880. — View Citation

Fernandes JL. MRI for Iron Overload in Thalassemia. Hematol Oncol Clin North Am. 2018 Apr;32(2):277-295. doi: 10.1016/j.hoc.2017.11.012. — View Citation

Inati A, Noureldine MA, Mansour A, Abbas HA. Endocrine and bone complications in beta-thalassemia intermedia: current understanding and treatment. Biomed Res Int. 2015;2015:813098. doi: 10.1155/2015/813098. Epub 2015 Mar 5. — View Citation

Kattamis A, Forni GL, Aydinok Y, Viprakasit V. Changing patterns in the epidemiology of beta-thalassemia. Eur J Haematol. 2020 Dec;105(6):692-703. doi: 10.1111/ejh.13512. Epub 2020 Sep 21. — View Citation

Mariotti S, Pigliaru F, Cocco MC, Spiga A, Vaquer S, Lai ME. beta-thalassemia and thyroid failure: is there a role for thyroid autoimmunity? Pediatr Endocrinol Rev. 2011 Mar;8 Suppl 2:307-9. — View Citation

Musallam KM, Cappellini MD, Viprakasit V, Kattamis A, Rivella S, Taher AT. Revisiting the non-transfusion-dependent (NTDT) vs. transfusion-dependent (TDT) thalassemia classification 10 years later. Am J Hematol. 2021 Feb 1;96(2):E54-E56. doi: 10.1002/ajh.26056. Epub 2020 Dec 9. No abstract available. — View Citation

Ray S, Saikia D, Vashisht Y, Sharma S, Meena RK, Kumar M. Dyslipidemia and atherogenic indexes in children with transfusion-dependent thalassemia. Hematol Transfus Cell Ther. 2023 Apr 22:S2531-1379(23)00075-5. doi: 10.1016/j.htct.2023.02.006. Online ahead of print. — View Citation

Vichinsky E. Non-transfusion-dependent thalassemia and thalassemia intermedia: epidemiology, complications, and management. Curr Med Res Opin. 2016;32(1):191-204. doi: 10.1185/03007995.2015.1110128. Epub 2015 Nov 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia	HbA1c in thalassemia major versus intermediate	24 month