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CTRI Number  CTRI/2022/03/041035 [Registered on: 11/03/2022] Trial Registered Prospectively
Last Modified On: 10/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Single Arm Study 
Public Title of Study   Effect of Dr Dixit Lifestyle on HbA1c level  
Scientific Title of Study   Lifestyle intervention of Daily Two Only Meals and Exercise (2-OMEX/Dr Dixit Lifestyle) to determine change in HbA1c levels in Type 2 Diabetes and Pre Diabetes: A self controlled preventive study in employees of Chitale group at Bhilawadi, Tal.Palus, Dist. Sangli, Maharashtra, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jagannath Vinayak Dixit 
Designation  Professor 
Affiliation  B.J.Government Medical College 
Address  Professor Cabin, Department of Community Medicine, B.J.Government Medical College, Jay Prakash Narayan Road, Near Pune Railway Station, Pune
Professor Cabin, Department of Community Medicine, B.J.Government Medical College, Jay Prakash Narayan Road, Near Pune Railway Station, Pune
Pune
MAHARASHTRA
411001
India 
Phone  9922994777  
Fax    
Email  drjvdixit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagannath Vinayak Dixit 
Designation  Professor 
Affiliation  B.J.Government Medical College 
Address  Professor Cabin, Department of Community Medicine, B.J.Government Medical College, Jay Prakash Narayan Road, Near Pune Railway Station, Pune
Professor Cabin, Department of Community Medicine, B.J.Government Medical College, Jay Prakash Narayan Road, Near Pune Railway Station, Pune
Pune
MAHARASHTRA
411001
India 
Phone  9922994777  
Fax    
Email  drjvdixit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jagannath Vinayak Dixit 
Designation  Professor 
Affiliation  B.J.Government Medical College 
Address  Professor Cabin, Department of Community Medicine, B.J.Government Medical College, Jay Prakash Narayan Road, Near Pune Railway Station, Pune
Professor Cabin, Department of Community Medicine, B.J.Government Medical College, Jay Prakash Narayan Road, Near Pune Railway Station, Pune
Pune
MAHARASHTRA
411001
India 
Phone  9922994777  
Fax    
Email  drjvdixit@gmail.com  
 
Source of Monetary or Material Support  
Chitale Brothers Bhilawadi, Palus, Sangli 
 
Primary Sponsor  
Name  Chitale group Bhilawadi 
Address  Tal Palus, Dist. Sangli, Maharashtra 
Type of Sponsor  Other [Company owner] 
 
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 Jagannath Vinayak Dixit  Professors cabin, Department of Community Medicine, BJ Government Medical College  Jai Prakash Narayan Road, Near Pune Railway Station
Pune
MAHARASHTRA 		 9922994777

drjvdixit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC of B.J.G.M.C. And Sasson General Hospital, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E663||Overweight, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2-OMEX or Dr Dixit Lifestyle  Person will be advised to eat only two meals when he is really hungry. He will be advised to walk for 4.5Km at a stretch everyday. In between two meals he will be allowed to drink water, thin home made buttermilk or black tea without any flavour. In none of these sugar/jaggery/honey/sugar substitute will be allowed. He will be asked to avoid all sweets in meals and fruits for first three months. He will maintain a diary to record everyday food items consumed and also exercise done. This lifestyle modification shall be applied everyday for one year 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Prediabetics with HbA1c from 5.7 to 6.4; People diagnosed with type 2 diabetes without any complications; may or may not be on anti diabetic medication; should be able to self report regarding meals and exercise 
 
ExclusionCriteria 
Details  Participants with diagnosed cardiovascular disease, nephropathy, retinopathy, neuropathy or diabetic foot; those unable to do exercise; those who do not give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in HbA1c by 1gm% in diabetics and 0.5 gm% in prediabetics  Every month for 12 months in diabetics and every three months for 12 months in prediabetics 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in BMI and waist circumference  Every three months for 12 months 
Reduction in dose and frequency of anti diabetes medicines in diabetics  At the beginning of study and after one year 
Reduction in HOMA-IR  At the beginning and after one year  
Diabetes remission %  After one year of beginning the study 
 
Target Sample Size   Total Sample Size="147"
Sample Size from India="147" 
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)   15/03/2022 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Diabetes is a widespread metabolic condition with an estimated 10% of the population in India being prediabetic and 10% being diabetic. The prevalence is on rise. The latest statement issued by American Diabetes Association regarding standards of medical care in diabetes and a consensus statement by the American College of Endocrinology and the American Association of Clinical Endocrinologists recommend lifestyle intervention as the preferred treatment option for prediabetes and newly diagnosed diabetes up to 3 months, as it has been shown to be safe and highly effective, reducing the progression to type 2 diabetes by more than 40%. Unfortunately the lifestyle suggested in present era which includes multiple small meals and exercise has failed to show its results. It is common to see that in almost all patients of type 2 diabetes, the doses and number of medicines for diabetes keep on increasing during the progress of disease. 
The principal investigator of this study has initiated "World free of obesity and diabetes" campaign in 2013. In this campaign 2 Only Meals and Exercise (2-OMEX) lifestyle popularly known as  Dr Dixit Lifestyle is advised to participants. In this lifestyle the person is supposed to eat only two meals when he/she is really hungry. In between two meals the person can take water, thin home made buttermilk and black tea (all these without adding sugar/jaggery/honey/sugar substitute). With this the person is supposed to walk for 4.5 Km at a stretch everyday. Research papers published so far indicate that this lifestyle causes average weight loss to the tune of 6.8 Kg in six months. It also causes reduction in fasting insulin level. It can also cause reversal of prediabetes status. Case report of diabetes remission is also published. 
The hypothesis is that by reducing eating frequency the insulin level in body decreases. This makes body to use fats for energy. It increases insulin sensitivity and reverses ill effects of insulin resistance. The present study is conducted with the aim to see effect of this lifestyle on HbA1c levels in prediabetes and diabetes and also to see the remission in diabetes. 
If the results are encouraging then we will have a lifestyle that is free of cost, does not require a doctor/expert, does not require you to buy any machine or nutritional supplements and most importantly one can follow it happily for life time!  
 
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