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Enhancing the Vagal Tone in Prediabetes Individuals

Primary Purpose

Prediabetes, Autonomic Nervous System Imbalance, Poor Glycemic Control

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HRV biofeedback
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prediabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tri-Service Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HRV biofeedback group

control group

Arm Description

8 once-a-week, individual, 30-min sessions of HRV biofeedback and 1 session of healthy lifestyle education

1 session of healthy lifestyle education

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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).
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.

Full Information

First Posted
July 31, 2018
Last Updated
February 24, 2020
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03616275
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Autonomic Nervous System Imbalance, Poor Glycemic Control, Psychological Distress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRV biofeedback group
Arm Type
Experimental
Arm Description
8 once-a-week, individual, 30-min sessions of HRV biofeedback and 1 session of healthy lifestyle education
Arm Title
control group
Arm Type
No Intervention
Arm Description
1 session of healthy lifestyle education
Intervention Type
Other
Intervention Name(s)
HRV biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from Baseline Autonomic function (Heart rate variability) at 3 and 6 months
Description
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).
Time Frame
baseline, 3-month, and 6-month visits
Secondary Outcome Measure Information:
Title
Changes from Baseline Psychological distress (Anxiety and Depression) at 3 and 6 months
Description
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.
Time Frame
baseline, 3-month, and 6-month visits
Title
Changes from Baseline perceived stress at 3 and 6 months
Description
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).
Time Frame
baseline, 3-month, and 6-month visits
Title
Changes from Baseline serum biomarkers (CRP, IL-6, BDNF, GAS6, HbA1c, and FPG) at 3 and 6 months
Description
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).
Time Frame
baseline, 3-month, and 6-month visits
Title
Changes from Baseline salivary cortisol at 3 and 6 months
Description
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.
Time Frame
baseline, 3-month, and 6-month visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Ju Chen, Ph.D.
Organizational Affiliation
National Defense Medical Center, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service Medical Center
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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