| CTRI Number |
CTRI/2024/08/073115 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Obesity and Overweight on Heart Filling Function |
|
Scientific Title of Study
|
Effect of Obesity and Overweight on Left Ventricular Diastolic Function in Adult Population-A Cross Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikita Chanana |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09958002910 |
| Fax |
|
| Email |
messinik17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath H Hande |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972597655 |
| Fax |
|
| Email |
manjunath.hande@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath H Hande |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972597655 |
| Fax |
|
| Email |
manjunath.hande@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine
Kasturba Hospital Manipal, Madhav Nagar, Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College, Madhav Nagar,Manipal,Karnataka,India,Pin Code-576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Nikita Chanana |
Kasturba Hospital Manipal |
Department of General Medicine
Kasturba Hospital,Manipal
Udupi
KARNATAKA |
9958002910
messinik17@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 - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I50||Heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who consent to the study and are obese or overweight according to criteria of having BMI more than 23 and with preserved left ventricular systolic function. |
|
| ExclusionCriteria |
| Details |
Those who have Hypertension
Those who have Type 2 diabetes mellitus
Those who have Coronary artery disease
Those who have Valvular Heart lesion
Those who have Acute infections
Those who have Chronic lung disease
Those who have Reduced ejection fraction
Those who have severe anemia
Those taking drugs affecting diastolic function of heart
Those who have Obstructive sleep apnea
Those who have chronic kidney disease
Those who are HIV positive
Those who are smokers or alcoholics
Those who have preexisting cardiomyopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the proportion of left ventricular diastolic dysfunction in obese and overweight adults |
Cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine diastolic dysfunction indices using a 2D echocardiogram & ascertain the relationship between BMI & left ventricular diastolic dysfunction |
cross sectional study |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/09/2024 |
| 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 Applicable |
| 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
|
Written and informed consent will be taken from the patient. Participants will be recruited from both in-patient and out-patient department age more than 18 years to 65 years. A few questions would be asked to collect the socio demographic details and patient file would be reviewed for lab reports and investigation results along with radiological imaging. 2D echocardiography would be done to assess the left ventricular diastolic function and features of left ventricular diastolic dysfunction will be noted. Data will be analyzed as per statistical methods mentioned, and an association between overweight and obesity and left ventricular diastolic dysfunction will be determined, so as to explore the utility in indian context. |