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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05118542
Other study ID # 19-06-0752
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2019
Est. completion date August 1, 2020

Study information

Verified date November 2021
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During July 2019 to August 2020, a single-blind clinical trial was done to 36 patients with Graves' disease. At the beginning of the study, subjects were accommodated into 2 groups, 17 into PTU groups and 19 into methimazole groups. There were 24 subjects who finished the study, 13 from PTU group and 11 from methimazole group. Blood serum was collected for HOMA-IR, LDL-R, NFĸB, sICAM-1, sVCAM-1 and sE-selectin examination. Meanwhile stiffness and thickness of carotid artery was measured using PWV and cIMT.


Description:

This study was a single blind, randomized clinical trial study, conducted in Cipto Mangunkusumo National Referral Hospital from January 2019 to August 2020. We included all adult patient aged 18-65 years with newly diagnosed Graves' disease or no prior anti-thyroid drugs medication for more than 1 month, who agreed to participate in the study. The exclusion criteria was pregnancy, history of coronary heart disease, known malignancy, current use of immunosuppressive medication, sepsis, thyroid crisis, or having allergic reaction to anti-thyroid drugs and other severe side effect. Ethical approval was obtained from the Research Ethics Committee of the Faculty of Medicine, Universitas Indonesia with approval number KET-784/UN.2.F1/ETIK/PPM.00.02/2019. Study participant was observed every month for 3 months. Anti-thyroid drugs (PTU or methimazole) were given according to true simple randomization with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist. At baseline visit, first and third month follow up, blood serum was collected to analyse HOMA-IR, LDL-R, NFĸB, sICAM-1, sVCAM-1 and sE-selectin, meanwhile PWV and cIMT were measured using radiofrequency ultrasound examination of carotid arteries. Categorical data was presented in frequency (%), while numerical data was presented using mean (SD) if normally distributed or median (IQR) if not normally distributed. Correlation Pearson test was performed for normal distributed data and Spearman test for not normal distributed data. To analyze the changes in parameter from baseline, first and third month, repeated ANOVA and General Linear Model test was performed. For not normally distributed data, transformation into normally distributed data was performed and the data was presented as geometric mean (CI 95%).


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date August 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adult patients aged 18-65 years - Newly diagnosed Graves' disease or no prior anti-thyroid drugs medication for more than 1 month - Agreed to participate in the study Exclusion Criteria: - Pregnancy - History of coronary heart disease - Known malignancy - Current use of immunosuppressive medication sepsis, thyroid crisis - Having allergic reaction to anti-thyroid drugs and other severe side effect

Study Design


Intervention

Drug:
Propylthiouracil
PTU were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.
Methimazole
methimazole were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.

Locations

Country Name City State
Indonesia University of Indonesia Jakarta Pusat Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

Bano A, Chaker L, Mattace-Raso FUS, van der Lugt A, Ikram MA, Franco OH, Peeters RP, Kavousi M. Thyroid Function and the Risk of Atherosclerotic Cardiovascular Morbidity and Mortality: The Rotterdam Study. Circ Res. 2017 Dec 8;121(12):1392-1400. doi: 10.1161/CIRCRESAHA.117.311603. Epub 2017 Oct 31. — View Citation

Bilir C, Gökosmanoglu F, Caliskan M, Cinemre H, Akdemir R. Regression of the carotid intima media thickness by propylthiouracil therapy in Graves' hyperthyroidism. Am J Med Sci. 2012 Apr;343(4):273-6. doi: 10.1097/MAJ.0b013e31822a8284. — View Citation

Inaba M, Henmi Y, Kumeda Y, Ueda M, Nagata M, Emoto M, Ishikawa T, Ishimura E, Nishizawa Y. Increased stiffness in common carotid artery in hyperthyroid Graves' disease patients. Biomed Pharmacother. 2002 Jul;56(5):241-6. — View Citation

Rizos CV, Elisaf MS, Liberopoulos EN. Effects of thyroid dysfunction on lipid profile. Open Cardiovasc Med J. 2011;5:76-84. doi: 10.2174/1874192401105010076. Epub 2011 Feb 24. — View Citation

Upala S, Wirunsawanya K, Jaruvongvanich V, Sanguankeo A. Effects of statin therapy on arterial stiffness: A systematic review and meta-analysis of randomized controlled trial. Int J Cardiol. 2017 Jan 15;227:338-341. doi: 10.1016/j.ijcard.2016.11.073. Epub 2016 Nov 9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pulse Wave Velocity Pulse wave velocity was measured using radio frequency ultrasound in supine position at both left and right carotid artery Change from Baseline to 3 month follow-up
Primary carotid intima media thickness cIMT was measured using radio frequency ultrasound in supine position at both left and right carotid artery Change from Baseline to 3 month follow-up
Secondary HOMA-IR HOMA-IR was calculated from patient fasting blood glucose and fasting insulin, which both were obtained through serum of the patient. Fasting blood glucose was measured using ECLIA methods with Abbott reagent, while fasting insulin were measured using ELISA with D&G International Inc. kit Change from Baseline to 3 month follow-up
Secondary LDL-R LDL-R was measured from the patient serum using ELISA with D&G International Inc. kit Change from Baseline to 3 month follow-up
Secondary NFkB NFkB was measured from the patient serum using ELISA with Cusabio kit Change from Baseline to 3 month follow-up
Secondary sICAM-1 sICAM-1 was measured from the patient serum using ELISA with D&G International Inc. kit Change from Baseline to 3 month follow-up
Secondary sVCAM-1 sVCAM-1 was measured from the patient serum using ELISA with D&G International Inc. kit Change from Baseline to 3 month follow-up
Secondary sE-selectin sE-selectin was measured from the patient serum using ELISA with D&G International Inc. kit Change from Baseline to 3 month follow-up
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