| CTRI Number |
CTRI/2018/06/014486 [Registered on: 11/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
14/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study of salivary biomarkers in prediabetes and Type 2 diabetes |
|
Scientific Title of Study
|
Study of association of salivary adipokines with prediabetes and Type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinitha Ramachandran |
| Designation |
Consultant Periodontitis |
| Affiliation |
Dr A Ramachandran s Diabetes Hospitals |
| Address |
Dr A Ramachandran s Diabetes Hospitals
No 28 Marshall s Road
Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9841045133 |
| Fax |
|
| Email |
vinitha7@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinitha Ramachandran |
| Designation |
Ph.D Student |
| Affiliation |
Dr A Ramachandran s Diabetes Hospitals |
| Address |
Dr A Ramachandran s Diabetes Hospitals
No 28 Marshall s Road
Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9841045133 |
| Fax |
|
| Email |
vinitha7@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Raghavan |
| Designation |
Consultant |
| Affiliation |
Dr A Ramachandran s Diabetes Hospitals |
| Address |
Dr A Ramachandran s Diabetes Hospitals
No 28 Marshall s Road
Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9884060066 |
| Fax |
|
| Email |
raghavank@hotmail.com |
|
|
Source of Monetary or Material Support
|
| India Diabetes Research Foundation
No 28 Marshalls Raod Egmore Chennai 600008 |
|
|
Primary Sponsor
|
| Name |
India Diabetes Research Foundation |
| Address |
No 28 Marshall s Road
Egmore
Chennai 600008
|
| 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 |
| Dr Vinitha Ramachandran |
Dr A Ramachandran s Diabetes Hospitals |
Dental Department
Room No 202
No 28 Marshall s Road
Egmore
Chennai
TAMIL NADU |
04428414311
vinitha7@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandrans Diabetes Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Prediabetes and Type 2 diabetes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Arm 1 Fasting plasma glucose test (FPG) - less than 110mg/dl and Oral glucose tolerance test (OGTT) - less than 140 mg/dl
2.Arm 2 Fasting plasma glucose test (FPG) – more than or equal to 110mg/dl to less than 126 mg/dl, Oral glucose tolerance test (OGTT) - more than or equal to 140mg/dl to less than or equal 199 mg/dl
3.Arm 3 Fasting plasma glucose (FPG) more than or equal to 126 mg/dL, and/or 2-hPG(2-hour post load plasma glucose) more than or equal to 200 mg/dL
4.Person given written informed consent to participate in this study in accordance with local regulations
5.Person must be available for and willing to attend all evaluation visits
|
|
| ExclusionCriteria |
| Details |
1.Smokers for over a period of 6 months (1 or more cigarettes per day)
2.Betel nut chewer over a period of 3 months
3.Person with bleeding disorders
4.Person who require antibiotic prophylaxis prior to dental treatment
5.History of antibiotic therapy within 3 months prior to the study
6.Person with uncontrolled systemic disease
7.Person not willing to participate in the study
8.Individuals who are cognitively impaired and/or who are unable to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in adipokines level in saliva between normal, prediabetic and Newly diagnosed diabetic patients at the end of 2yrs |
Baseline and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the following parameters at 2 yrs between normal, prediabetic and Newly diagnosed diabetic patients
1. Weight , BMI and Blood Pressure
2. Fasting and 2hr Postprandial Blood Glucose
3. Treatment within the group
4. Occurrence of any complication
|
Baseline and 24 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2015 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
India has more than 65 million adults with Type 2 Diabetes Mellitus (T2DM) and also has a large number with subclinical stages of glycaemia including impaired fasting glucose (IFG) and impaired glucose tolerance (IGT). At present people with high risk of diabetes are identified by blood test such as Oral glucose tolerance Test and/or glycosylated haemoglobin A1c (HbA1c). Dysregulated actions of adipokines have major roles in development of metabolic diseases such as diabetes. Adipokines influence systemic insulin resistance and also regulate inflammatory process and/or are likely to have major pathological role in the development of diabetes. It is also likely that these abnormalities occur even in sub clinical stages of T2DM which when identified would provide an early opportunity to institute early intervention using life style changes which are proven to be effective in all ethnic groups.The measurements of adipokines such as adiponectin, apelin, visfatin and vaspin which have inter related regulatory roles, in saliva if found to be sensitive would provide a non-invasive, simple method of assessing persons with high risk of T2DM. |