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CTRI Number  CTRI/2018/03/012528 [Registered on: 13/03/2018] Trial Registered Retrospectively
Last Modified On: 09/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Behavioral 
Study Design  Other 
Public Title of Study   Role of biomarkers in diabetes  
Scientific Title of Study   Role of specific inflammatory markers and adipokines in relation to insulin resistance and β-cell function.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mary Josephine Priscilla S 
Designation  Research Officer  
Affiliation  India Diabetes Research Foundation  
Address  No28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone  04428414311  
Fax    
Email  pris.mj14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mary Josephine Priscilla  
Designation  Research Officer  
Affiliation  India Diabetes Research Foundation  
Address  No28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone  04428414311  
Fax    
Email  pris.mj14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mary Josephine Priscilla  
Designation  Research Officer  
Affiliation  India Diabetes Research Foundation  
Address  No28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone  04428414311  
Fax    
Email  pris.mj14@gmail.com  
 
Source of Monetary or Material Support  
India Diabetes Research Foundation No. 28 Marshalls Road Egmore Chennai 600008  
 
Primary Sponsor  
Name  India Diabetes Research Foundation  
Address  No 28 Marshalls Road Egmore Chennai 600008 
Type of Sponsor  Research institution and hospital 
 
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 
Prof A Ramachandran   India Diabetes Research Foundation   Department of Epidemiology, Second Floor No 28 Marshalls Road Egmore 600008
Chennai
TAMIL NADU 
4428414311

ramachandran@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  Prediabetes and Newly diagnosed diabetes  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lifestyle modification   Thrice weekly text messages to motivate participants to follow healthy lifestyle changes Messages are based on improvements in diet and physical activity 
Comparator Agent  Standard Care   General advice on lifestyle changes at baseline alone  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Both Men and women with no history of diabetes
Persons with 3 or more of the following risk factors for diabetes
a Age 35 to 55 years
b Positive family history of diabetes
c Body mass index greater than 23kg per m2
d Waist circumference more than 90cm for men and more than 80cm for women
e Hypertension
f Sedentary habits

Persons with prediabetes having HbA1c values between 6 percent and less than 6 point 5 percent  
 
ExclusionCriteria 
Details  Known diabetes
Any other illness
Unwilling to participate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Differences between baseline levels of visfatin resistin chemerin and fetuinA in cases developing T2DM and in normoglycaemia   24 months  
 
Secondary Outcome  
Outcome  TimePoints 
Effect of lifestyle factors on study parameters

Association of visfatin resistin chemerin and fetuinA with insulin resistance and β-cell function.
 
12 and 24 months  
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/04/2016 
Date of Study Completion (India) 21/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None as yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The pathogenesis of diabetes explains the fact that early inflammatory and immune mechanisms are elemental in the disease progression predisposing the condition to diabetes. The currently available gold standard clinical markers of diabetes; fasting blood glucose, oral glucose tolerance test and HbA1c efficiently reflects blood glucose status but does not provide an elaborate information on the pathological process involved in the early stages of the disease.

There is a complex cluster of factors associated with diabetes; insulin resistance, hyperglycaemia, dyslipidaemia, hypertension, hyperinsulinaemia, systemic inflammation and adipose-tissue derived compounds. It is evident that no single factor can precisely assess the individuals risk status of diabetes. The inflammatory and immune marker profile varies in the course of the development of the disease. This heterogeneity enables differentiation between the early preclinical and clinical phases of its progression. Identification of novel biomarkers presented at the initial stages of subclinical inflammation may be used to refine diabetes risk prediction and target individuals for suitable intervention.

It is important to correlate clinical markers of glucose levels (fasting plasma glucose, HbA1c), markers of metabolism (resistin, visfatin) and inflammatory markers (CD 36, CD 26) to present a lucid representation of the risk profile of diabetes. Therefore a prospective study in subjects with prediabetes is being taken up with the objective to study the above parameters that are likely to have a significant role with the interrelated metabolic conditions of insulin resistance and β-cell function. For the proposed study the population will be incident T2DM cases (n=80) as defined by the WHO criteria of HbA1c ≥6.5% and those reverted to normoglycaemic status HbA1c <5.7% (n=80). When combined the study of biomarkers will be performed in 160 samples.   Circulating levels of sCD36, sCD26, serum visfatin and serum resistin will be analysed using commercial kits for Enzyme linked Immuno Sorbent Assay (ELISA).  If these markers are identified as independent predictors of insulin resistance, they can serve as suitable tools to be applied in disease prognosis for prediabetes and cardiovascular risk. This is an exploratory analysis of the main study entitled “A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent Type 2 diabetes in India and the UK”, CTRI/2014/07/004799.     

 
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