Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis
- Sponsor
- Indonesia University
- Study ID
- NCT05118542
- Phase
- PHASE3
- Status
- Completed
Conditions
- Atherosclerosis of Artery
- Graves Disease
- Hyperthyroidism
- Pathophysiology
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Propylthiouracil — DRUGPTU were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.
- Methimazole — DRUGmethimazole were given to participants with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist.
Study Details
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.
Key Dates
- Start date
- Jan 1, 2019
- Status verified
- Nov 2021
- Primary completion
- Jun 1, 2020
- Completion
- Aug 1, 2020
Study Design
- Enrollment
- 36 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: PTU GroupPropylthiouracil (PTU) was given with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist
- Active Comparator: Methimazole GroupMethimazole was given with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist
Primary Outcome Measure
Pulse Wave Velocity [ Time Frame: Change from Baseline to 3 month follow-up ]
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