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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  
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 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  
Status 
Not Applicable 
 
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.

 
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