| CTRI Number |
CTRI/2024/03/064596 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Physiotherapy (Not Including YOGA) Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Retrospective analysis to see the effect of Freedom from diabetes protocol on management of prediabetes/type 2 diabetes/obesity in India |
|
Scientific Title of Study
|
A Retrospective Analysis to Assess the Effect of an Integrated Intensive Lifestyle Intervention among Individuals with Prediabetes /Type 2 Diabetes/Obesity in India |
| Trial Acronym |
NIL |
|
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
Pune MAHARASHTRA 411004 India |
| Phone |
9822792772 |
| Fax |
|
| Email |
drpramod@freedomfromdiabetes.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Manager, Research |
| 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
Pune MAHARASHTRA 411004 India |
| Phone |
9822792772 |
| Fax |
|
| Email |
kadam.nidhi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Manager, Research |
| 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
MAHARASHTRA 411004 India |
| Phone |
9822792772 |
| Fax |
|
| Email |
kadam.nidhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Freedom from Diabetes Research Foundation |
|
|
Primary Sponsor
|
| Name |
Freedom from diabetes research foundation (Host Institution) |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India |
| 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.1,Parth, Ghodke Chowk Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India Pune MAHARASHTRA |
9822792772
kadam.nidhi@gmail.com |
|
|
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 |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 75 years
2. Confirmed diagnosis of prediabetes or type 2 diabetes and/or BMI more than 23 kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Diabetes type other than type 2 like LADA, MODY, gestational
2. Those with complete data |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.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.
2. BMI below 23 or least 3 point drop
3. Reduction in mental health scores to below 10
4. At least 10% improvement in lipid levels
|
Weight, HbA1c and lipid profile at Baseline, 6 month, 1 year
Mental health questionnaire at baseline and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other biochemical parameters like serum creatinine, eGFR, SGPT, SGOT, urine microalbumiuria, C-reactive protein. |
Biochemical parameters will be assessed at baseline, 6 months and at 1 year |
|
|
Target Sample Size
|
Total Sample Size="20000" Sample Size from India="20000"
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)
|
27/03/2024 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The Freedom from Diabetes Clinic has been running a lifestyle intervention program for managing diabetes and its complications since its inception in 2013. As such, this comprehensive retrospective analysis aims to explore the effect of the integrated lifestyle management approach that combines diet, exercise, stress, and medical management in patients enrolled in the FFD intensive lifestyle intervention program for diabetes management. Additionally, this study aims to understand population-specific disease and metabolic characteristics along with mental health and stress-related issues, the prevalence of comorbidities, and their impact on glycemic control, and to explore the associations between these parameters in this cohort. Based on retrospective data extracted, the specific objectives of the study are: A) To assess the impact of the ILI (post-intervention effects) on remission (defined as maintaining HbA1c less than 6.5% without the use of glucose-lowering medications), glycemic control, weight loss, reduction in medication use, improvement in comorbidities (hypertension, dyslipidemia, nephropathy, anxiety, depression, diabetes-related stress), and complications (nephropathy). B) To analyze the baseline characteristics of patients diagnosed with T2D and prediabetes who attended an ILI-based diabetes management program. C) To investigate the associations between clinical, anthropometric, biochemical, and mental health outcomes. |