| CTRI Number |
CTRI/2024/03/064537 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the relationship of salivary hs-CRP with the regular cardiovascular risk factors and HbA1c in prediabetic patients. |
|
Scientific Title of Study
|
Correlation of salivary hs-CRP with conventional cardiovascular risk markers and HbA1c in prediabetic subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam Bedi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher education and research |
| Address |
Department of General Medicine, Datta Meghe Institute of Higher Education and Research, JNMC, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9672634064 |
| Fax |
|
| Email |
sarang141@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sourya Acharya |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher education and research |
| Address |
Department of General Medicine, Datta Meghe Institute of Higher Education and Research, JNMC, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9511840372 |
| Fax |
|
| Email |
souryaacharya74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Bedi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher education and research |
| Address |
Department of General Medicine, Datta Meghe Institute of Higher Education and Research, JNMC, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9672634064 |
| Fax |
|
| Email |
sarang141@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research, Sawangi (Meghe), Wardha-442001, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Dr Gautam Bedi |
| Address |
Department of General Medicine, Datta Meghe Institute of Higher Education and Research, JNMC, Sawangi, Wardha, Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
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 Gautam Bedi |
Datta Meghe Institute Of Higher Education and Research |
Department of Medicine, JNMC, Datta Meghe Institute Of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India.
Wardha
MAHARASHTRA |
9672634064
sarang141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute Of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the consenting patients of 45 years and above with risk factors, attending medicine OPD or getting admitted in medicine ward of DMIHER Wardha. |
|
| ExclusionCriteria |
| Details |
1. Patients refusing informed consent
2. Patients who have previous diagnosis of diabetes mellitus.
3. Patients suffering from iron deficiency and sickle cell anemia.
4. Patients receiving HIV treatment.
5. Pregnancy
6. Postpartum patients
7. Patients on hemodialysis and chronic kidney disease
8. Patients with chronic liver disease
9. Patients who have received recent blood transfusion or are on erythropoietin therapy.
10. Patients who have undergone salivary gland surgery.
11. Patients who are smokers and alcoholics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| salivary HsCRP in prediabetic subjects |
on day 1 morning between 9am-11am. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Cholesterol, HDL, LDL, VLDL, Triglycerides, HbA1C, Body Mass Index, Waist Circumference, Waist Hip Ratio, Neck Circumference in prediabetic subjects. |
on day 1 After 8 hours of overnight fast |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
05/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IT IS A CROSS SECTIONAL OBSERVATIONAL STUDY IN WHICH CORRELATION OF SALIVARY HS-CRP WILL BE DONE WITH CONVENTIONAL CARDIO VASCULAR RISK MARKERS AND HBA1C IN PRE DIABETIC SUBJECTS WITH THE PURPOSE TO SAVE MANY PREDIABETICS FROM CONVERTING INTO OVERT DIABETES AND ALSO DECREASE THE PREDISPOSITON TO CARDIAC DISEASE. THIS WILL ALSO HELP TO REDUCE THE IMMENSE ECONOMIC BURDEN ON THE SOCIETY. |