| CTRI Number |
CTRI/2024/04/065340 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Beating Type 2 Diabetes: An integrated approach through behavioural and dietary interventions to achieve remission |
|
Scientific Title of Study
|
Remission of Type 2 Diabetes Mellitus through Dietary and Behavioural interventions: A Randomised controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| INT/IEC/2024/SPL 67 Version 1 dated 18 Feb 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunjeet Singh |
| Designation |
PhD Scholar |
| Affiliation |
PGIMER Chandigarh |
| Address |
Dept of communuity Medicine and School of Public Health PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9168203366 |
| Fax |
|
| Email |
warinmytime@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof JS Thakur |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Dept of communuity Medicine and School of Public Health PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463602173 |
| Fax |
|
| Email |
jsthakur64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arunjeet Singh |
| Designation |
PhD Scholar |
| Affiliation |
PGIMER Chandigarh |
| Address |
Dept of communuity Medicine and School of Public Health PGIMER Chandigarh
Dept of communuity Medicine and School of Public Health PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9168203366 |
| Fax |
|
| Email |
warinmytime@gmail.com |
|
|
Source of Monetary or Material Support
|
| Implementation reserach grant of Rs 25,000 by World NCD Federation. The study will be conducted. The study will be conducted in Indira colony , field practice area of Dept of community medicine and school of public health PGIMER |
|
|
Primary Sponsor
|
| Name |
Implementation Research Grant of Rs 25,000 won for conducting Doctoral work |
| Address |
11 Karuna Sadan Building Sector 11 A Chandigarh |
| Type of Sponsor |
Other [NGO ] |
|
|
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 Arunjeet Singh |
Indira Colony , Manimajra , UT of Chandigarh |
Urban Health Training Centre Dept of Community Medicine and School of Public Health PGIMER Chandigarh
Chandigarh
CHANDIGARH |
9168203366
warinmytime@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary and Behavioural intyervention |
Intervention in the study will start with baseline assessment of eligible participants for enrolment in the trial.
Randomisation of eligible participants in each of the arms will be done through stratified randomisation in which the participants in the intervention and control arm will be further sub stratified having Type 2 Diabetes Mellitus less than and more than 2 years.
Randomised withdrawal design may be considered in our study in which case the total sample size will be 100
The dietary intervention in the case will be consisting of a millet-based diet, low carbohydrate diets and a overall emphasis on a balanced diet will be reinforced. The dietary intervention in the instant case will be designed keeping the purchasing power of the participants in perspective
Behavioural change intervention will be done through promotion of physical activity smoking cessation and alcohol cessation. The physical activity will be for 60 minutes daily as per the recommendation of guidelines on physical activity and sedentary behaviour. The comparator in the study will continue to receive standard care. The intervention arm will be dietary and behavioural intervention and comparator arm will continue to receive the standard care . The total duration of the intervention is 9 months
|
| Comparator Agent |
The Comparator agent in our trial will be standard care in which the patient will continue to receive the treatment as prescribed by the physician |
The comparator in our case will be standard care which the patients will continue to receive . In that way we will ensure that the patients in comparator arm will continue to receive the care and are not at a disadvantage. The total duration of the intervention is 9 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study
Patients satisfying the diagnostic criteria of Type 2 Diabetes Mellitus as per HEARTS D Module and World NCD Federation guidelines
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study
Patients with Type 1 Diabetes
Pre-diabetes
Patients on Insulin
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(a) Number of patients with behavioural and dietary interventions who achieved remission in patients
(b) What is acceptability and understand barriers to adopt dietary interventions especially millets
(c) IEC material in hindi the form of hand bills/ booklets for promotion and acceptability of dietary and behavioural interventions
|
(a) Number of patients with behavioural and dietary interventions who achieved remission in patients
(b) What is acceptability and understand barriers to adopt dietary interventions especially millets
(c) IEC material in hindi the form of hand bills/ booklets for promotion and acceptability of dietary and behavioural interventions
The patients will be assessed at baseline , 3 months , 6 months and 9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of patients with Hypertension who became normotensive at the end of 9th month |
The data pertaining to hypertensive patients became normotensive at the end of 9th month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/04/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The study titled " Achieving remission in patients with Type 2 Diabetes Mellitus through Behavioural and dietary interventions : A Randomised Control Trial" will begin with recruitment after permission is received from CTRI . The primary study objective is to acheive remission in patients with Type 2 Diabetes Mellitus using dietary and behavioural interventions . The dietary intervention will consist of administration of a Millet based and a low carbohydrate diet , the behavioural intervention will include graded assimilation of physical activity , yoga session , awareness about diabetes and associated complications, tobacco and alcohol cessation . IEC activities will be conducted in the form of face to face interviews and group sessions . The intervention will be for 6 months and subsequently the patients will be randomised into intervention and control group at the end of sixth month and will be followed up for further 3 months, The end of trial assessment will be carried out at the end of 9th month in which remission status acheived will be observed . The number of study sites in the trial will be 1 and prior permission of IEC of PGIMER Chandigarh has been obtained |