PrediabetesNCT03616275
Enhancing the Vagal Tone in Prediabetes Individuals
A study testing HRV biofeedback in people with Prediabetes and Autonomic Nervous System Imbalance, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prediabetes, Autonomic Nervous System Imbalance, Poor Glycemic Control
- What is being tested?
- HRV biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Oct 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 20 or more
- fasting blood glucose level of 100 to 125 mg/dl
- HbA1C value of 5.7% to 6.4%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- HRV biofeedback
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV biofeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HRV biofeedback group | Experimental | 8 once-a-week, individual, 30-min sessions of HRV biofeedback and 1 session of healthy lifestyle education Receives: Other: HRV biofeedback |
| control group | No intervention | 1 session of healthy lifestyle education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Autonomic function (Heart rate variability) at 3 and 6 months
Heart rate variability (HRV) was used to represent the autonomic function, and measured with Mind Media B.V. (NeXus-10, Netherlands). Time and frequency domains of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland).
Measured: baseline, 3-month, and 6-month visits
Secondary outcomes (4)
Changes from Baseline Psychological distress (Anxiety and Depression) at 3 and 6 months
The hospital anxiety and depression scale was a 14-item ordinal scale, used for participants to self-rate their psychological distress related to anxiety (7 items) and depression (7 items). Items are scored 0(no distress) to 3 (serious distress). Based on the findings from previous studies, scoring at or higher than the cut-off point of 8 out of 21, identified those with anxiety or depression.
Measured: baseline, 3-month, and 6-month visits
Changes from Baseline perceived stress at 3 and 6 months
Perceived stress was measured using the Chinese version of the Perceived Stress Scale (PSS), through which the participants self-reported about how they cope with, react to, and feel about various stressors. The PSS is a 5-point scale that ranges from 0 (never) to 4 (very often) with 14 items (seven negative and seven positive).
Measured: baseline, 3-month, and 6-month visits
Changes from Baseline serum biomarkers (CRP, IL-6, BDNF, GAS6, HbA1c, and FPG) at 3 and 6 months
All blood will be drawn in the morning, between 8 and 10 a.m., and will immediately be separated by centrifugation at 2000 r/min for 10 minutes at 4 oC. CRP, BDNF, and GAS6 will be measured with a sandwich enzyme-linked immunoassay (ELISA) using a DuoSet ELISA Development kit (R\&D Systems Catalog # DY1707). IL-6 will be measured by the BD™ CBA Human Soluble Protein Flex Set System with discrete fluorescence intensities to detect soluble analytes at very low concentrations. The HbA1c value will be measured by high-performance liquid chromatography, using the Primus CLC385 (Primus Corporation, Kansas City, MO). The FPG will be measured using a Reflotron reflectance photometric analyzer (Boehringer Mannheim, Germany).
Measured: baseline, 3-month, and 6-month visits
Changes from Baseline salivary cortisol at 3 and 6 months
Participant will be requested to collect the saliva before breakfast, approximately 30 minutes after awakening and before they brushed their teeth. The sample will be immediately frozen and transported to the laboratory for cortisol concentration measurement and analyzed using a commercial ELISA kit (Calbiochem, Darmstadt, Germany). All salivary variables are normalized by salivary flow rate.
Measured: baseline, 3-month, and 6-month visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start17 Oct 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ju Chen, National Defense Medical Center, Taiwan
- Investigators
- Yu-Ju Chen, Ph.D., Principal investigator, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616275
- Sponsor's protocol ID
- 2-106-05005
- Status last verified
- Feb 2020
- First submitted
- 31 Jul 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Glycemic Regulation and the Psychoneuroimmunological Function by Enhancing the Vagal Tone in Prediabetes Individuals
- ClinicalTrials.gov ID
- NCT03616275
- Acronym / sponsor ID
- 2-106-05005
- Conditions
- Prediabetes, Autonomic Nervous System Imbalance, Poor Glycemic Control, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV biofeedback group | Experimental | Other: HRV biofeedback8 once-a-week, individual, 30-min sessions of HRV biofeedback and 1 session of healthy lifestyle education |
| control group | No intervention | –1 session of healthy lifestyle education |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 20 or more
- fasting blood glucose level of 100 to 125 mg/dl
- HbA1C value of 5.7% to 6.4%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV biofeedbackHRV 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. | Other | HRV biofeedback group |
Primary outcome
Changes from Baseline Autonomic function (Heart rate variability) at 3 and 6 months
Time frame: baseline, 3-month, and 6-month visits
Heart rate variability (HRV) was used to represent the autonomic function, and measured with Mind Media B.V. (NeXus-10, Netherlands). Time and frequency domains of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland).
4 secondary outcomes
Changes from Baseline Psychological distress (Anxiety and Depression) at 3 and 6 months
Time frame: baseline, 3-month, and 6-month visits
Changes from Baseline perceived stress at 3 and 6 months
Time frame: baseline, 3-month, and 6-month visits
Changes from Baseline serum biomarkers (CRP, IL-6, BDNF, GAS6, HbA1c, and FPG) at 3 and 6 months
Time frame: baseline, 3-month, and 6-month visits
Changes from Baseline salivary cortisol at 3 and 6 months
Time frame: baseline, 3-month, and 6-month visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Ju Chen, Ph.D. principal investigator
National Defense Medical Center, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV biofeedback in people with Prediabetes and Autonomic Nervous System Imbalance, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Autonomic function (Heart rate variability) at 3 and 6 months (time frame: baseline, 3-month, and 6-month visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.