NCT03616275

Enhancing the Vagal Tone in Prediabetes Individuals

Improving the Glycemic Regulation and the Psychoneuroimmunological Function by Enhancing the Vagal Tone in Prediabetes Individuals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prediabetes
• Autonomic Nervous System Imbalance
• Poor Glycemic Control
• Psychological Distress

Interventions

Type	Name	Description
OTHER	HRV biofeedback	HRV biofeedback protocol is modified from Lehrer's HRV biofeedback manual (2000), which had been successfully used to improve functioning and quality of life for patients with asthma and COPD. A noninvasive biofeedback system with a NeXus-10 with BioTrace+ (Mind Media B.V., Netherlands) and laptop computer will be used for biofeedback intervention. The intervention protocol is including paced breathing in resonant frequency, abdominal breathing and pursed-lip breathing, and visual biofeedback. The designed intervention protocol will include 8 once-a-week, individual, 20-min in hospital training sessions and twice-a-day, 20-min home self-practices.

Timeline

• Start date: 2017-10-17
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2018-08-06
• Last updated: 2020-02-26

Locations

1 site across 1 country: Taiwan