Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis
Condition: Hyperthyroidism; Graves Disease; Atherosclerosis of Artery; Pathophysiology
MeSH terms: Graves Disease; Atherosclerosis; Hyperthyroidism
Study type: Interventional
Phase: Phase 3

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%).
    

Intervention name(s): Propylthiouracil; Methimazole
Intervention type(s): Drug; Drug
Intervention description(s): PTU were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.; methimazole were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.
Intervention MeSH terms: Methimazole; Propylthiouracil
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperthyroidism; Graves Disease; Atherosclerosis; Pathophysiology; Insulin Resistance; Lipid Marker; Inflammatory Marker; PWV; cIMT