| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes
|
|
|
Intervention / Comparator Agent
|
|
|
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. | |