Prediabetes Clinical Trial
Official title:
Improving the Glycemic Regulation and the Psychoneuroimmunological Function by Enhancing the Vagal Tone in Prediabetes Individuals
This is a 2-year course of study. A randomized control trial will be conducted, in which 90 prediabetes individuals will be recruited and randomly assigned them into the wait-list control group or experimental group to test the effectiveness of 8 once-a-week, individual, 20-min sessions of HRV biofeedback on modulating vagal tone, glycemic control, psychological wellbeing, and inflammatory status in this population. Its longitudinal effects will be evaluated after 3- and 6-month follow-up.
Background. Compared to healthy population, individuals with prediabetes have a higher risk
to develop diabetes and other cardiovascular diseases. However, these downward progressions
might positively associate with autonomic nervous dysfunction, especially low vagal tone,
which can be detected prior to comorbidities confirmed. The significant correlations among
low autonomic nervous, high psychological distress, inflammatory status, and poor glycemic
regulation, which are regarded as the psychoneuroimmunological integration, have not been
well studied in prediabetes individuals. Heart rate variability (HRV) biofeedback is an easy
and noninvasive intervention, which has been confirmed to strengthen baroreflex stimulation,
facilitate the modulation of vagal tone, and further promote the physiological and
psychological wellbeing in various diseases but not in prediabetes.
Objective. To test the effectiveness of HRV biofeedback on the modulating vagal tone and
further enhancing the psychoneuroimmunological integration related to glycemic control,
anti-inflammatory reaction, and psychological wellbeing.
Research methods. In this 2-year RCT study, the investigators are planning to recruit 90
prediabetes individuals and randomly assigned them into wait-list control group or
experimental group by using the random sequence of numbers generated from the Excel Bernoulli
Function. Experimental group will receive 8 once-a-week, individual, 30-min sessions of HRV
biofeedback and 1 session of healthy lifestyle education. During the biofeedback training
period, subjects will be encouraged to self- home practice of resonant frequency breathing
for 20 mins, twice-a-day. Control group will receive 1 session of healthy lifestyle
education. All subjects will be repeatedly assessed at time of enrollment, post-training (8
weeks after enrollment), 3-month, and 6-month follow-up. Repeated assessments will include
physiological measurements of HRV, BDNF, GAS6, HbA1c, CRP, IL- 6, FPG, and salivary cortisol,
and psychological measurements of perceived stress, anxiety, and depression.
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