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

NCT ID: NCT05118542

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-01

Brief Summary

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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

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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%).

Conditions

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Hyperthyroidism Graves Disease Atherosclerosis of Artery Pathophysiology

Keywords

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Hyperthyroidism Graves Disease Atherosclerosis Pathophysiology Insulin Resistance Lipid Marker Inflammatory Marker PWV cIMT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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

Study Groups

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PTU Group

Propylthiouracil (PTU) was given with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist

Group Type ACTIVE_COMPARATOR

Propylthiouracil

Intervention Type DRUG

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

Methimazole Group

Methimazole was given with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist

Group Type ACTIVE_COMPARATOR

Methimazole

Intervention Type DRUG

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

Interventions

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Propylthiouracil

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

Intervention Type DRUG

Methimazole

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Wismandari

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 29089349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21660244 (View on PubMed)

Bilir C, Gokosmanoglu 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.

Reference Type BACKGROUND
PMID: 21825964 (View on PubMed)

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. doi: 10.1016/s0753-3322(02)00195-6.

Reference Type BACKGROUND
PMID: 12199623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27839806 (View on PubMed)

Wisnu W, Alwi I, Nafrialdi N, Pemayun TGD, Pantoro NI, Wijaya CN, Tahapary DL, Tarigan TJE, Subekti I. The Effects of Anti-thyroid Drugs on Lipoproteins and Insulin Resistance in Graves' Disease: A Randomized Clinical Trial. J Lipid Atheroscler. 2024 Sep;13(3):358-370. doi: 10.12997/jla.2024.13.3.358. Epub 2024 Jun 12.

Reference Type DERIVED
PMID: 39355401 (View on PubMed)

Other Identifiers

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19-06-0752

Identifier Type: -

Identifier Source: org_study_id