| 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
|
|
|
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
|
|
|
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 UKâ€, CTRI/2014/07/004799. |