FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065375 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of guided training on sensations and functioning of heart in patients of diabetes mellitus 
Scientific Title of Study   Effect of heart rate variability biofeedback training on peripheral sensory status and cardiac autonomic status in type 2 diabetes mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akanksha Singh 
Designation  Additional Professor 
Affiliation  AIIMS 
Address  2026A, Teaching block, Department of Physiology AIIMS New Delhi
New Delhi
South
DELHI
110029
India 
Phone  8377933797  
Fax    
Email  drakanksha111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akanksha Singh 
Designation  Additional Professor 
Affiliation  AIIMS 
Address  2026A, Teaching block, Department of Physiology AIIMS New Delhi
New Delhi
South
DELHI
110029
India 
Phone  8377933797  
Fax    
Email  drakanksha111@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monica Rawat 
Designation  MD student 
Affiliation  AIIMS 
Address  Teaching block, Department of Physiology, AIIMS, New Delhi
New Delhi
South
DELHI
110029
India 
Phone  9810611875  
Fax    
Email  monicarawat2507@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Ansari Nagar, New Delhi, INDIA - 110029 
 
Primary Sponsor  
Name  AIIMS 
Address  AIIMS New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Monica Rawat  All India Institute of Medical Sciences  Biofeedback Clinic, Room no. 2050, Department of Physiology, 2nd Floor, Teaching Block, AIIMS , Ansari Nagar, New Delhi - 110029
New Delhi
DELHI 
9810611875

monicarawat2507@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee for post graduate research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  The control arm will only be receiving standard therapy.  
Intervention  HRV Biofeedback  The HRV Biofeedback group will be receiving 8 weeks of HRV biofeedback intervention with each session of 10 minutes of every day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Age: 18-50 years
2 Type 2 diabetes mellitus
 
 
ExclusionCriteria 
Details  1 Neuropathic pain due to causes other than diabetes
2 Central nervous system lesions
3 History indicating a disease, condition, or treatment that might be a potential cause of polyneuropathy other than diabetes
4 Blunted response to deep breathing test with delta heart rate less than 5 during deep breathing
5 Yogic breathing or meditation practitioners practicing supervised or unsupervised sessions one or more than once per week in the last 6 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in heart rate variability (time and frequency domain)
2. Change in peripheral sensory profile (Quantitative sensory testing)
3. Change in glycemic status (Fasting blood glucose, HbA1c)
 
At the end of 4 weeks of heart rate variability biofeedback training. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in heart rate variability (time & frequency domain)
2. Change in peripheral sensory profile (Quantitative sensory testing)
3. Change in glycemic status (Fasting blood glucose, HbA1c) 
At 8 weeks. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by high blood sugar levels due to insulin resistance when the body cannot fully respond to insulin. Diabetic neuropathy is traditionally considered a common complication of diabetes which can present in the form of distal symmetrical polyneuropathy (DSPN) and cardiac autonomic neuropathy (CAN). Distal symmetrical polyneuropathy affects up to 50% of adults with long-term diabetes. Quantitative sensory testing (QST) is a non-invasive tool in which standardized testing procedures allow the quantification of somatosensory functions. Very few studies have quantified peripheral neuropathic status in T2DM using QST but all have reported dysfunction in T2DM. The overall prevalence of cardiac autonomic neuropathy among patients with T2DM is approximately 20 - 73%. It is characterized by impairment of the parasympathetic and sympathetic components of the autonomic nervous system. CAN is a significant cause of morbidity and mortality associated with a high risk of cardiac arrhythmias and sudden death. Heart rate variability (HRV) is a simple non-invasive tool commonly employed to evaluate cardiac autonomic status. A high rate of neuropathic complications indicates the need for investigation into new therapeutic modalities. Heart rate variability biofeedback (HRVB) training is a non-invasive tool that has been shown to be an effective adjunct to standard therapy in various disorders. Very few studies have investigated the effects of HRVB in T2DM patients. Furthermore, no information from any randomized controlled trial for the same is available. Therefore, the present randomized controlled trial is planned to study the effect of HRVB training on the peripheral sensory and cardiac autonomic neurological profile in patients of T2DM.

 
Close