Hyperthyroidism, Graves Disease, Atherosclerosis of Artery, Pathophysiology
Conditions
Keywords
Hyperthyroidism, Graves Disease, Atherosclerosis, Pathophysiology, Insulin Resistance, Lipid Marker, Inflammatory Marker, PWV, cIMT
Brief 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.
Detailed 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%).
Interventions
DRUGPropylthiouracil
PTU were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.
DRUGMethimazole
methimazole were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The care providers gave two choice of drug doses to the research assistant. The research assistant then give the participant their drugs based on the assignment from the randomisation. The investigator and outcome assessor were blinded to the drugs which the participants received
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Wave Velocity | Change from Baseline to 3 month follow-up | Pulse wave velocity was measured using radio frequency ultrasound in supine position at both left and right carotid artery |
| carotid intima media thickness | Change from Baseline to 3 month follow-up | cIMT was measured using radio frequency ultrasound in supine position at both left and right carotid artery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NFkB | Change from Baseline to 3 month follow-up | NFkB was measured from the patient serum using ELISA with Cusabio kit |
| sICAM-1 | Change from Baseline to 3 month follow-up | sICAM-1 was measured from the patient serum using ELISA with D&G International Inc. kit |
| HOMA-IR | Change from Baseline to 3 month follow-up | 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 |
| sE-selectin | Change from Baseline to 3 month follow-up | sE-selectin was measured from the patient serum using ELISA with D&G International Inc. kit |
| sVCAM-1 | Change from Baseline to 3 month follow-up | sVCAM-1 was measured from the patient serum using ELISA with D&G International Inc. kit |
| LDL-R | Change from Baseline to 3 month follow-up | LDL-R was measured from the patient serum using ELISA with D&G International Inc. kit |
Countries
Indonesia
Outcome results
None listed