Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis: Review on the Pathway of Insulin Resistance, Lipid, Inflammation, and Endothelial Dysfunction to Pulse Wave Velocity and Carotid Intima-Media Thickness
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- carotid intima media thickness
研究概览
简要总结
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.
详细描述
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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PTU Group
Propylthiouracil (PTU) was given with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist
干预措施: Propylthiouracil (Drug)
Methimazole Group
Methimazole was given with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist
干预措施: Methimazole (Drug)
结局指标
主要结局
carotid intima media thickness
时间窗: 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
Pulse Wave Velocity
时间窗: 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
次要结局
- HOMA-IR(Change from Baseline to 3 month follow-up)
- LDL-R(Change from Baseline to 3 month follow-up)
- NFkB(Change from Baseline to 3 month follow-up)
- sVCAM-1(Change from Baseline to 3 month follow-up)
- sE-selectin(Change from Baseline to 3 month follow-up)
- sICAM-1(Change from Baseline to 3 month follow-up)
研究者
Wismandari
Assistant Professor
Indonesia University