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CTRI Number  CTRI/2018/04/012962 [Registered on: 03/04/2018] Trial Registered Retrospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of Diabetes and Cardiovascular Risk Factors 
Scientific Title of Study   A study of the secular trends in the prevalence of glucose intolerance and cardiovascular risk factors among populations in Southern India 
Trial Acronym  PHS  
Secondary IDs if Any  
Secondary ID  Identifier 
IDRFARH004  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A Ramachandran 
Designation  Principal Investigator  
Affiliation  India Diabetes Research Foundation  
Address  Dr.A.Ramachandrans Diabetes Hospitals Second Floor Department of Epidemiology No 28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone    
Fax    
Email  research@ardiabetes.org  
 
Details of Contact Person
Scientific Query
 
Name  A Ramachandran 
Designation  Principal Investigator  
Affiliation  India Diabetes Research Foundation  
Address  Dr.A.Ramachandrans Diabetes Hospitals Second Floor Department of Epidemiology No 28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone    
Fax    
Email  research@ardiabetes.org  
 
Details of Contact Person
Public Query
 
Name  A Ramachandran 
Designation  Principal Investigator  
Affiliation  India Diabetes Research Foundation  
Address  Dr.A.Ramachandrans Diabetes Hospitals Second Floor Department of Epidemiology No 28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone    
Fax    
Email  research@ardiabetes.org  
 
Source of Monetary or Material Support  
India Diabetes Research Foundation 
 
Primary Sponsor  
Name  India Diabetes Research Foundation  
Address  No 28 Marshalls Road Egmore  
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 
DrARamachandran  DrARamachandrans Diabetes Hospitals   Second Floor No 28 Marshalls Road Egmore
Chennai
TAMIL NADU 
04428414311

research@ardiabetes.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of India Diabetes Research Foundation and DrARamachandrans Diabetes Hospitals   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Diabetes  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  Willing to consent for participation and provide informed consent form.

 
 
ExclusionCriteria 
Details  Terminal illness and cognitive impairment  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Temporal changes in prevalence rates of T2DM IGT and IFG among the target population   10 year  
 
Secondary Outcome  
Outcome  TimePoints 
Temporal changes in risk factors associated with diabetes dysglycaemia and cardiovascular risk in an urban and periurban setting

Changes in lifestyle parameters with urbanisation in the rural population

Assessment of prevalence of dysglycaemia among adolescents 
10 year  
 
Target Sample Size   Total Sample Size="11000"
Sample Size from India="11000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/05/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Series of epidemiological studies have been carried out by the research team since 1988 studying the changes in the prevalence of T2DM, prediabetes and associated risk factors. These studies have shown that the determinants to rising prevalence of diabetes vary among populations and with time. Comparative studies from the same region can help to understand the temporal changes occurring in a specific population. In this proposal we intend to conduct a cross-sectional survey in varied levels of urbanisation and compare the findings with our earlier reported data to assess the degree of changes in dysglycaemic prevalences. The primary aim of the proposal is to study the temporal changes and the prevalence of diabetes, prediabetes and associated cardio-metabolic risk factors in varying levels of urbanization. A multi-stage random selection method will be used. Field workers will conduct an enumeration of the individuals above 20 years of age. In each location, streets will be randomly selected to have an equal representativeness from different socio-economic strata. All eligible occupants (family members) of the selected households will be invited for the survey. The study outcomes will be of relevance in public health research in modeling effective national healthcare policies.

 
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