Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05643365
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 131
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients	Radiation: Radioactive Iodine therapy

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].

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Hypothyroidism decreased hormone levels (FT3 < 3.5 pmol/L, FT4 < 11.5 pmol/L, TSH > 4.78 μU/mL) and symptoms of hypothyroidism within 6 months' follow-up.	Radiation: Radioactive Iodine therapy; All the patient need to stop ATD and iodine-containing drugs for 5 days prior to RAI treatment, and followed a low-iodine diet for 2 weeks. After fasting and water deprivation for 8 h, all the patients took RAI orally in the morning. After taking RAI, the patients need to continue fasting and water deprivation for extra 2 h to avoid the effects of food on iodine absorption.
Euthyroidism normal hormone levels (FT3 3.5 to 6.5 pmol/L, FT4 11.5 to 22.7 pmol/L, TSH 0.55 to 4.78 μU/mL), and no symptoms of hyperthyroidism after 6 months' follow-up	Radiation: Radioactive Iodine therapy; All the patient need to stop ATD and iodine-containing drugs for 5 days prior to RAI treatment, and followed a low-iodine diet for 2 weeks. After fasting and water deprivation for 8 h, all the patients took RAI orally in the morning. After taking RAI, the patients need to continue fasting and water deprivation for extra 2 h to avoid the effects of food on iodine absorption.
Hyperthyroidism increased hormone levels (FT3 > 6.5 pmol/L, FT4 > 22.7 pmol/L, TSH < 0.55 μU/mL) and symptoms of hyperthyroidism after 6 months' follow-up	Radiation: Radioactive Iodine therapy; All the patient need to stop ATD and iodine-containing drugs for 5 days prior to RAI treatment, and followed a low-iodine diet for 2 weeks. After fasting and water deprivation for 8 h, all the patients took RAI orally in the morning. After taking RAI, the patients need to continue fasting and water deprivation for extra 2 h to avoid the effects of food on iodine absorption.

Outcome Measures

Primary Outcome Measures

1. predictive factors of early hypothyroidism after RAI therapy [1 year]

   Retrospective study from 2013 to 2022 to analyze the correlation between clinical, demographic& and laboratory data and incidence of hypothyroidism by measuring thyroid function tests

Secondary Outcome Measures

1. the incidence of hypothyroidism within 1 year [10 years]

   To detect the frequency of hypothyroidism after RAI and when it is most likely occur after 6 months or one year

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuclear medicine unit, department of clinical oncology and nuclear medicine, Assiut university hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

• Study Director: Hemat A Mahmoud, M.D, Lecturer
• Study Chair: Hanan G Mostafa, M.D, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.

• Responsible Party: Aya Abdel-Baset Ahmed Ali Alsanory, Resident in nuclear medicine departement (South Egypt Cancer institute), Assiut University
• ClinicalTrials.gov Identifier: NCT05643365
• Other Study ID Numbers: Hypothyroidism after RAI
• First Posted: Dec 8, 2022
• Last Update Posted: Dec 12, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Graves Disease; Hypothyroidism

Study Results

No Results Posted as of Dec 12, 2022