Clinical trial NCT03616275: Enhancing the Vagal Tone in Prediabetes Individuals
Official title: Improving the Glycemic Regulation and the Psychoneuroimmunological Function by Enhancing the Vagal Tone in Prediabetes Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Autonomic Nervous System Imbalance
Poor Glycemic Control
Psychological Distress
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* aged 20 or more
* fasting blood glucose level of 100 to 125 mg/dl
* HbA1C value of 5.7% to 6.4%

Exclusion Criteria:

* lack of Chinese literacy
* visual and hearing deficits
* the presence of arrhythmia
* previous diagnosed with diabetes
* any other serious physical illness (e.g. severe neurocognitive disorders or evidence of cor pulmonale) or psychiatric disorders

Primary outcomes:
measure: Changes from Baseline Autonomic function (Heart rate variability) at 3 and 6 months
timeFrame: baseline, 3-month, and 6-month visits
Secondary outcomes:
measure: Changes from Baseline Psychological distress (Anxiety and Depression) at 3 and 6 months
timeFrame: baseline, 3-month, and 6-month visits
measure: Changes from Baseline perceived stress at 3 and 6 months
timeFrame: baseline, 3-month, and 6-month visits
measure: Changes from Baseline serum biomarkers (CRP, IL-6, BDNF, GAS6, HbA1c, and FPG) at 3 and 6 months
timeFrame: baseline, 3-month, and 6-month visits
measure: Changes from Baseline salivary cortisol at 3 and 6 months
timeFrame: baseline, 3-month, and 6-month visits
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service Medical Center
Study officials:
affiliation: National Defense Medical Center, Taiwan
name: Yu-Ju Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: