Enhancing the Vagal Tone in Prediabetes Individuals

NCT03616275 | Completed

• 1 other identifier: 2-106-05005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline, 3-month, and 6-month visits

Secondary Outcomes (4)

• Changes from Baseline Psychological distress (Anxiety and Depression) at 3 and 6 months

  baseline, 3-month, and 6-month visits

• Changes from Baseline perceived stress at 3 and 6 months

  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

  baseline, 3-month, and 6-month visits

• Changes from Baseline salivary cortisol at 3 and 6 months

  baseline, 3-month, and 6-month visits

Study Arms (2)

HRV biofeedback group

EXPERIMENTAL

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

Other: HRV biofeedback

control group

NO INTERVENTION

1 session of healthy lifestyle education

Interventions

HRV biofeedback OTHER

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.

HRV biofeedback group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-Service Medical Center

Taipei, Taiwan

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yu-Ju Chen, Ph.D.

  National Defense Medical Center, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: October 17, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

TW (1)