Clinical trial NCT06377865: Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia
Official title: Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: B Thalassemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient aged18 and older ,both gender. patient diagnosed B thalassemia major \&intermediate

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia
timeFrame: 24 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yes
name: Mostafa Haridy, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2024 Oct-Dec;46(4):345-351. doi: 10.1016/j.htct.2023.02.006. Epub 2023 Apr 22.
citation: 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.
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.
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.
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.
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.
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.