| 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
|
|
|
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
|
|
|
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. |