| CTRI Number |
CTRI/2023/08/056822 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ASSESMENT OF HEART FUNCTION BY ECHO IN DIABETIC PATIENTS WITH EYE INVOLVEMENT |
|
Scientific Title of Study
|
ASSESMENT OF LEFT HEART FUNCTION BY STRAIN ECHO IN DIABETIC PATIENTS WITH RETINOPATHY |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Ayush Sharma |
| Designation |
Junior resident, Department of General Medicine |
| Affiliation |
Kasturba Medical College and Hopital |
| Address |
Department of General Medicine,
Kasturba Hospital,
Manipal,
Udupi-576104,
Karnataka
Department of General Medicine,
Kasturba Hospital,
Manipal,
Udupi-576104,
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9799894141 |
| Fax |
|
| Email |
ayushkush0047@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sneha Seshadri |
| Designation |
Assistant Professor, Department of General Medicine |
| Affiliation |
Kasturba Medical College and Hopital |
| Address |
Department of General Medicine
Kasturba Hospital
Manipal
Udupi-576104
Karnataka
Department of General Medicine
Kasturba Hospital
Manipal
Udupi-576104
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9799894141 |
| Fax |
|
| Email |
sne287@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ayush Sharma |
| Designation |
Junior resident, Department of General Medicine |
| Affiliation |
Kasturba Medical College and Hopital |
| Address |
Department of General Medicine
Kasturba Hospital
Manipal
Udupi-576104
Karnataka
Department of General Medicine
Kasturba Hospital
Manipal
Udupi-576104
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9799894141 |
| Fax |
|
| Email |
ayushkush0047@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,
Manipal,
Udupi-576104,
Karnataka |
|
|
Primary Sponsor
|
| Name |
Ayush Sharma |
| Address |
Department of General Medicine,
Kasturba Hospital,
Manipal,
Udupi-576104,
Karnataka |
| 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 |
| AYUSH SHARMA |
Kasturba Hospital |
Department of General Medicine,
Kasturba Hospital,
Manipal,
Udupi-576104,
Karnataka
KARNATAKA
Udupi
KARNATAKA |
9799894141
ayushkush0047@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics commitee-2 (student Reseach) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NILL |
NILL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Males and Females above the age of 18 years living with Type 2 diabetes Mellitus willing to be evaluated for Retinopathy, and to undergo a cardiac evaluation by strain ECHO between August 2022 to August 2024 |
|
| ExclusionCriteria |
| Details |
1. Known Coronary Artery disease.
2. Newly diagnosed Coronary artery disease by non invasive tests such as ECHO/ Tread mill test.
3. Pre-existing Congestive cardiac failure.
4. Moderate to severe valvular heart disease.
5. Pre-existing Occular anomalies, like eyeball tumours, occular trauma, enucleation of eyes.
6. Left ventricular Ejection Freaction of less than 50 percent.
7. Chronic Kidney Disease (grade 2 or above).
8. Poor window prohibiting strain ECHO analysis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Left Ventricular & Left Atrial Strain parameters using ECHO in diabetic patients with and without retinopathy and establish a co-relation |
At the end of sample collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To corelate findings of Strain ECHO parameters acreoss stages of Diabetic Nephropathy |
Once data collection is complete & sample size is achieved the primary outcome will be measured |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
10/09/2023 |
| 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="1"
Months="1"
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
|
The study involves comparison of 2 groups of diabetic individuals, those with and those without diabetic retinopathy and the presence of left sided cardiac dysfunction in them by using strain ECHO parameters. It is an observational cross sectional study. Approximately 126 patients with 63 in each group (diabetic patients with retinopathy and other group of diabetic patients without retinopathy) will be participating in the study after explaining to them about the study and taking their informed consent. Patients will be subjected to routine history taking and a general physical examination along with routine blood investigations like glycosylated hemoglobin, Fasting blood sugars, Fasting lipid profile, Post prandial blood sugars, urine routine examination and urine protein to creatine ration. And routine non invasive investigations like a fundoscopy. Apart from this these patients will undergo a routine ECHO cardiography, ECG to fullfil the inclusion and exclusion criteria. Then the patients will be subjected to a strain ECHO in which various parameters as mentioned in the proforma for assessment of Left sided heart failure will be assesed. The outcome will then be compared in the form of presence and association of left sided cardiac dysfunction with diabetic retinopathy and nephropathy. |