| CTRI Number |
CTRI/2023/06/053885 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral
Nutraceutical
Other (Specify) [Lifestyle modification ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Freedom from diabetes protocol on weight loss and HbA1c improvement in patient with Type 2 diabetes in India |
|
Scientific Title of Study
|
Efficacy of lifestyle intervention program on management & remission of type 2 diabetes and its complications – DiRemI study |
| Trial Acronym |
DiRemI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Tripathi |
| Designation |
Director |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk
Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
drpramod@freedomfromdiabetes.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Research Manager |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.7,Parth, Ghodke Chowk
Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Research Manager |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.7,Parth, Ghodke Chowk
Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
|
Source of Monetary or Material Support
|
| Freedom from diabetes research foundation (Host Institution) |
|
|
Primary Sponsor
|
| Name |
Freedom from diabetes research foundation |
| Address |
Parth, Ghodke Chowk,
Prabhat Road, Pune |
| 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 Nidhi Kadam |
Freedom from Diabetes Clinic |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.7,Parth, Ghodke Chowk
Prabhat Road, Pune
Pune
MAHARASHTRA |
9822792772
research@freedomfromdiabetes.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Freedom from Diabetes Research Foundation- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle modification |
The duration of the intervention is 1-year. Intervention will consist of Plant-based diet, Physical activity (strength, stamina flexibility exercises including yoga), stress management (Counselling sessions and meditation), routine medical management |
| Comparator Agent |
Routine medical Care |
The duration of the intervention is 1-year. Control group will receive Routine medical care (RMC) aiming at education, support, and medical management of diabetes and associated co-morbidities, based on current clinical guidelines |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Written informed consent.
2. Men and women aged 30-70 years.
3. T2D duration <15 years.
4. Confirmed diagnosis of type 2 Diabetes- All patients on treatment with oral hypoglycemic agents and/or Insulin or any Ayurvedic anti-diabetic medications or HbA1c ≥ 48 mmol/mol (6.5%) with or without medication.
5. Body mass index (BMI) >25 kg/m2 and <35 kg/m2.
6. Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation.
7. Well-oriented in time, space & as a person.
|
|
| ExclusionCriteria |
| Details |
1. Type 1 diabetes (due to autoimmune b-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood).
2. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young), diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation).
3. Gestational diabetes mellitus (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation).
4. eGFR<45mL/min/1.73m2 and/or albuminuria ≥300mg).
5. Known history of retinopathy or neuropathy.
6. Previous history of heart attack, cardiac arrhythmia, bypass or stent placement surgery, ischemic heart disease, Angina (Class III & IV), myocardial infarction within the previous 6 months, reported heart failure (reduced LV ejection fraction ≤40%), ECG not within normal limits, reported positive stress test which is moderate to severe.
7. A known diagnosis of cancer.
8. Pregnant or lactating women.
9. Patients who have required hospitalization for any diabetes-related complications in the last 6 months or for depression or are on antipsychotic drugs.
10. Physical ailments (like spine issues, arthritis, etc.) that limit the implementation of the exercise protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At least 10% reduction in weight at one year & HbA1c less than 6.5% or 48 mmol/mol without the use of pharmacotherapy at 1 year. |
HbA1c & weight will be measured at baseline, at 6 months & at the end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a) Mental Health (in terms of reduction in scores below 10 for both anxiety & depression), b) Improvement in Co-morbidities & diabetes-related complications (nephropathy), c) Biochemical parameters e.g., Improvement in-Serum Lipids, Fasting and post prandial plasma glucose, creatinine/eGFR. |
For Mental health- At baseline & at 6 months
Co-morbidities & complications- At baseline, 6 months & at 12 months
For biochemical parameters- AT baseline, at 6 months and at end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
01/07/2023 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study is a open labelled, non-randomized, parallel-controlled trial that aims to study the effectiveness of DiRemI protocol in improving glycemic control in patients with Type 2 diabetes. The primary hypothesis is that the intervention which comprises of lifestyle modification with a plant-based diet, exercise, psychological support, and medical management, will result in weight-loss induced diabetes remission and improvement in glycemic control of patient with type 2 diabetes. The primary objective is to implement the intervention that will aim for the remission of diabetes by achieving reduction in weight at one year and HbA1c < 6.5% or 48 mmol/mol without the use of pharmacotherapy at 1 year. The secondary objective is to assess the effect of the intervention on other aspects of diabetes outcomes such as- a) Mental Health (in terms of anxiety and depression), b) Co-morbidities and diabetes-related complications (nephropathy), c) Biochemical parameters e.g., Serum Lipids, Fasting and post prandial plasma glucose, creatinine/eGFR. The duration of the intervention will be 18 months (12 months intervention + 6 month follow-up). Data will be collected at 3 time points: at the baseline, at 6-months, and at the end of 1 year of intervention. Adherence data will be collected from patients. |