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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

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 Group
    Propylthiouracil (PTU) was given with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist
  • Active Comparator: Methimazole Group
    Methimazole 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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