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Completed

NCT Number: NCT05118542

Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis

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.

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Key information

Conditions

Hyperthyroidism Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerosis of Artery Autoimmune Diseases Cardiovascular Diseases Endocrine System Diseases Exophthalmos Eye Diseases Glucose Metabolism Disorders Goiter Graves Disease Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Orbital Diseases Pathophysiology Thyroid Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propylthiouracil

Drug

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

methimazole

Drug

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

Primary outcomes

  1. Pulse Wave Velocity

    Time frame: 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

  2. carotid intima media thickness

    Time frame: 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 outcomes

  1. HOMA-IR

    Time frame: 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

  2. LDL-R

    Time frame: Change from Baseline to 3 month follow-up

    LDL-R was measured from the patient serum using ELISA with D&G International Inc. kit

  3. NFkB

    Time frame: Change from Baseline to 3 month follow-up

    NFkB was measured from the patient serum using ELISA with Cusabio kit

  4. sICAM-1

    Time frame: Change from Baseline to 3 month follow-up

    sICAM-1 was measured from the patient serum using ELISA with D&G International Inc. kit

  5. sVCAM-1

    Time frame: Change from Baseline to 3 month follow-up

    sVCAM-1 was measured from the patient serum using ELISA with D&G International Inc. kit

  6. sE-selectin

    Time frame: Change from Baseline to 3 month follow-up

    sE-selectin was measured from the patient serum using ELISA with D&G International Inc. kit

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2021
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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