| CTRI Number |
CTRI/2024/02/063176 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of heart function between non hypertensive diabetics and non diabetics with similar LV thickness |
|
Scientific Title of Study
|
Comparison of left ventricular diastolic function between normotensive diabetics and non-diabetics with similar left ventricular mass index |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi K S |
| Designation |
Postgraduate student |
| Affiliation |
Manipal college of health professions |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology MCHP MAHE Manipal Udupi Karnataka
Balkudru, Hungarcutta post,Udupi-576218
Udupi
KARNATAKA
576104
India |
| Phone |
8748969970 |
| Fax |
|
| Email |
rashmiks2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Vidya Nayak |
| Designation |
Assistant professor Dept of CVT |
| Affiliation |
Manipal college of health professions MAHE Manipal |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology MCHP MAHE Manipal Udupi Karnataka
Udupi
KARNATAKA
5762104
India |
| Phone |
9844624003 |
| Fax |
|
| Email |
vidya.madhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Vidya Nayak |
| Designation |
Assistant professor Dept of CVT |
| Affiliation |
Manipal college of health professions MAHE Manipal |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology MCHP MAHE Manipal Udupi Karnataka
Udupi
KARNATAKA
5762104
India |
| Phone |
9844624003 |
| Fax |
|
| Email |
vidya.madhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology Kasturba Medical College Manipal
Department of Cardiovascular Technology MCHP MAHE
|
|
|
Primary Sponsor
|
| Name |
KMC,MCHP MAHE,Manipal |
| Address |
KMC and Hospital Tiger circle road Madhava Nagar Manipal Udupi Karnataka,576104 |
| 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 |
| Dr Mahidhar Jeedigunta |
KMC Manipal |
Department of Cardiology, KMC, Manipal
Udupi
KARNATAKA |
9592914956
jmahidharsarma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Case
Diabetic patients who are on curative lifestyle modification or antidiabetic medication
Individuals who are not hypertensives
Controls
Non diabetic patients with same LV mass as case group |
|
| ExclusionCriteria |
| Details |
Genetically triggered causes of LV hypertrophy
Metabolic storage disorders
Valvular heart diseases producing LV obstruction
Preexisting systolic dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Peak E velocity
Peak A velocity
Pulsed wave TDI velocities |
At the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pulmonary venous doppler
LV volume index
Velocity propagation |
At the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="642"
Sample Size from India="642"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="612" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After departmental presentation, IRC, IEC approval and CTRI registration will be done. Patients will be enrolled in the study according to the inclusion criteria. Study details will be explained to the subjects, PIS will be provided and written informed consent will be obtained. Details about clinical history, findings on physical examination, investigations including biochemical tests will be noted. Standard echocardiographic views will be recorded along with connected ECG. Echocardiographic parameters of diastolic function are noted. The researcher is just observing and documenting the findings from the case. For controls these tests are standard of care. |