B ThalassemiaNCT06377865
Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia
An observational study of B Thalassemia, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B Thalassemia
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: patient aged18 and older ,both gender. patient diagnosed B thalassemia major \&intermediate
Who may be able to join
- patient aged18 and older
- both gender
- patient diagnosed B thalassemia major
- patient diagnosed B thalassemia intermediate
Who cannot join
- thalaasemia trait
- age less than 18
- type 1 D.M
- pt known thyroid \&recive tttt
Trial locations and contacts
No sites are listed yet.
About this study
to evaluate thyroid function ,HbA1C,\&lipid profile in thalassemic patient to correlate thyroid function , Hba1c , lipid profile e ferritin level in thalassemic patient
Read the 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.
- Conditions
- B Thalassemia
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Beta thalassemia ( major) | |
| 2 | Beta thalassemia (intermediate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia
HbA1c in thalassemia major versus intermediate
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for B ThalassemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demiana Adel Aziz, Assiut University
- Investigators
- Mostafa Haridy, Prof, Principal investigator, Yes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377865
- Sponsor's protocol ID
- endocrine dis & B thalassemia
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25834825Ray 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.
PubMed 37147168Chatterjee 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.
PubMed 20001615Mariotti 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.
PubMed 21705983Fernandes 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.
PubMed 29458732Vichinsky 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.
PubMed 26479125Kattamis 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.
PubMed 32886826Musallam 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.
PubMed 33219703
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia
- ClinicalTrials.gov ID
- NCT06377865
- Acronym / sponsor ID
- endocrine dis & B thalassemia
- Conditions
- B Thalassemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Beta thalassemia ( major) |
| 2 | – | –Beta thalassemia (intermediate) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient aged18 and older ,both gender. patient diagnosed B thalassemia major \&intermediate
Key inclusion criteria (4 listed)
- patient aged18 and older
- both gender
- patient diagnosed B thalassemia major
- patient diagnosed B thalassemia intermediate
Key exclusion criteria (4 listed)
- thalaasemia trait
- age less than 18
- type 1 D.M
- pt known thyroid \&recive tttt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia
Time frame: 24 month
HbA1c in thalassemia major versus intermediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 25834825Inati 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.
- Background: PubMed 37147168Ray 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.
- Background: PubMed 20001615Chatterjee 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.
- Background: PubMed 21705983Mariotti 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.
- Background: PubMed 29458732Fernandes 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.
- Background: PubMed 26479125Vichinsky 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.
- Background: PubMed 32886826Kattamis 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.
- Background: PubMed 33219703Musallam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Haridy, Prof principal investigator
Yes
Questions about this trial
What is this clinical trial studying?
An observational study of B Thalassemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact demiana AD aziz, researcher (01551633796, nanaa3964@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06377865, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.