Clinical trial NCT05643365: Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease
Official title: Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All thyrotoxic patients treated with RAI

Brief summary: The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease.

Detailed description: Hyperthyroidism is a clinical syndrome caused by increased thyroid hormone in the blood, it can lead to multiple complications, including cardiac, hepatic, and hematologic system complications. More than 80% of hyperthyroidism are caused by Graves' disease (GD). 3% of women and 0.5% of men may suffer GD in their lifetime \[1\].

Radioactive iodine (RAI) therapy is an important treatment option for Graves' disease (GD), the main side effect of RAI treatment is hypothyroidism, and the factors resulting in hypothyroidism are still controversial \[2\]. Male gender, smaller thyroid weight, higher thyroid-stimulating hormone, and smaller thyroid volume are Suggested to be the main risk factors for early hypothyroidism \[2\]-\[3\].

Eligibility criteria: Inclusion Criteria:

1. Graves' disease patients after one year of RAI therapy .
2. Suppressed serum thyrotropin (TSH) \<0.55 µU/ml , elevated serum free triiodothyronine (FT3) \> 6.5 pmol/L , free thyroxin FT4 \>22.7 pmol/L .

Exclusion Criteria:

1. Patients with other causes of hyperthyroidism , such as toxic multinodular goiter and single toxic adenoma
2. Thyroid cancer
3. Recurrent GD
4. Previous Thyroid surgery
5. Patients can't complete the follow -up within 6 months.

Primary outcomes:
measure: predictive factors of early hypothyroidism after RAI therapy
timeFrame: 1 year
Secondary outcomes:
measure: the incidence of hypothyroidism within 1 year
timeFrame: 10 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Nuclear medicine unit, department of clinical oncology and nuclear medicine, Assiut university hospital
Study officials:
affiliation: Lecturer
name: Hemat A Mahmoud, M.D
role: STUDY_DIRECTOR
affiliation: Professor
name: Hanan G Mostafa, M.D
role: STUDY_CHAIR
References:
citation: Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
citation: Hu RT, Liu DS, Li B. Predictive factors for early hypothyroidism following the radioactive iodine therapy in Graves' disease patients. BMC Endocr Disord. 2020 May 29;20(1):76. doi: 10.1186/s12902-020-00557-w.
citation: Demir BK, Karakilic E, Saygili ES, Araci N, Ozdemir S. Predictors of Hypothyroidism Following Empirical Dose Radioiodine in Toxic Thyroid Nodules: Real-Life Experience. Endocr Pract. 2022 Aug;28(8):749-753. doi: 10.1016/j.eprac.2022.05.001. Epub 2022 May 7.