RESUMO
OBJECTIVE: The cold pressor test (CPT) has been shown a potential sympathoexcitatory stimulus which increases aortic pulse wave velocity and the aortic augmentation index, suggesting that noninvasively, arterial stiffness parameters are altered by the CPT. The cardio-ankle vascular index (CAVI) is widely used for reflecting arterial stiffness, and the ankle-brachial index (ABI) for evaluating peripheral artery disease in obesity. We aimed to assess CAVI and ABI in overweight young adults in the context of sympathetic activation by using the CPT. METHODS: 160 participants were divided into 2 groups: 86 normal-weight (body mass index [BMI] 18.50-22.99 kg/m2) and 74 overweight (BMI ≥23 kg/m2). The CPT was performed by immersing a participant's left hand into cold water (3-5°C) for 3 min, and CAVI and ABI assessment. RESULTS: At baseline, the CAVI in the overweight group was significantly less than that in the normal-weight group (5.79 ± 0.85 vs. 6.10 ± 0.85; p < 0.05). The mean arterial pressure (MAP) for overweight was significantly greater than that for normal-weight subjects (93.89 ± 7.31 vs. 91.10 ± 6.72; p < 0.05). During the CPT, the CAVI increased in both normal-weight and overweight subjects, the CAVI value was greater during the CPT in overweight subjects by 14.36% (6.62 ± 0.95 vs. 5.79 ± 0.85, p < 0.05) and in normal-weight subjects by 8.03% (6.59 ± 1.20 vs. 6.10 ± 0.85, p < 0.05) than those baseline values. The CPT evoked an increase in systolic blood pressure (SBP), diastolic BP (DBP), heart rate (HR,) and pulse pressure (PP) in both groups. After a 4-min CPT period, the CAVI returned values similar to the baseline values in both groups, and the SBP, DBP, MAP, and PP in overweight participants were significantly higher than those in normal-weight participants. However, there was no significant difference in the ABI at baseline, during CPT, and post-CPT in either group. CONCLUSIONS: Our results indicated that the CAVI was influenced by sympathetic activation response to the CPT in both normal-weight and overweight young adults. Specifically, during the CPT, the percentage change of the CAVI in overweight response was greater in normal-weight participants than baseline values in each group. The ABI was not found significantly associated with CPT. These findings suggesting that sympathoexcitatory stimulus by CPT influence CAVI results.
RESUMO
PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.
