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CTRI Number  CTRI/2023/11/060073 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 25/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study of correlation between Early Heart Failure and dyslipidemia in Newly detected Type 2 diabetes Mellitus population 
Scientific Title of Study   Correlation between dyslipidemia and Left Ventricular Diastolic dysfunction in Newly detected Asymptomatic Type 2 Diabetes Mellitus 
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 Gundeti Nikhil 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  Department of General Medicine, Second floor , OPD block, Kasturba Medical College, Manipal , Karnataka, 576104
Kasturba Medical College , Tiger circle Road , Madhav Nagar, Manipal, Udupi, Karnataka 576104 India
Udupi
KARNATAKA
576104
India 
Phone  8019774144  
Fax    
Email  nikhilgundeti02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shubhada 
Designation  Associate Professor, Department of General Medicine 
Affiliation  Katurba Medical College 
Address  Department of General Medicine, Second floor , OPD block, Kasturba Medical College, Manipal , Karnataka, 576104
Kasturba Medical College , Tiger circle Road , Madhav Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9844465447  
Fax    
Email  shubhada.u@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sindhu 
Designation  Assistant Professor, Department of General Medicine 
Affiliation  Kasturba Medical College 
Address  Department of General Medicine, Second floor , OPD block, Kasturba Medical College, Manipal , Karnataka, 576104
Kasturba Medical College , Tiger circle Road , Madhav Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9945376412  
Fax    
Email  sindhu14591@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Dr Gundeti Nikhil 
Address  Kasturba Medical College, Tiger Circle Road, Madhav Nagar , Manipal, Karnataka 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gundeti Nikhil  Kasturba Hospital  Department of General Medicine , Kastruba Medical College, Manipal, Udupi , Karnataka
Udupi
KARNATAKA 		 8019774144

nikhilgundeti02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ksturba Medical Colllege and Kasturba Hospital Institutional Ethics Committe - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients age >30 years to 65 years
2.Patients diagnosed with T2DM within 6 months of detection who give informed consent
3.FBS ≥ 126 mg/dL and 2-hr plasma glucose ≥200mg/dL during an OGTT, RBS ≥ 200 mg/dL with symptoms (polyuria, polydipsia, polyphagia, weight loss) and Hba1c > 6.5 % as per American Diabetes Association recommendations.
 
 
ExclusionCriteria 
Details 

1.Known cases of cardiac diseases- Vascular or Ischemic heart disease, heart failure (congestive cardiac failure), cardiomyopathy, atrial fibrillation on treatment.
2.Known hypertensive patients or patients with BP>130/90 mmHg at the time of diagnosis.
3.Known patients of Chronic kidney disease (eGFR < 60 mL/min/1.73m2)
4.Patients with Chronic pulmonary disease.
5.Patients with Thyroid dysfunction.
6.Patients with Severe Anemia and other Hemoglobinopathies.
7.Known cases of malignancies, on treatment.
8.Pregnant women.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the prevalence of left ventricular diastolic dysfunction in asymptomatic newly detected type 2 Diabetes mellitus.
To study the correlation of left ventricular diastolic dysfunction with dyslipidemia in asymptomatic newly detected type 2 Diabetes mellitus.

 		 At the time of recruitement
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the correlation of left ventricular diastolic dysfunction with Glycosylated Hemoglobin levels in asymptomatic newly detected type 2 Diabetes mellitus.  At the time of recruitement
 
 
Target Sample Size   Total Sample Size="113"
Sample Size from India="113" 
Final Enrollment numbers achieved (Total)= "113"
Final Enrollment numbers achieved (India)="113" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) 30/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/05/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  

NEED FOR THE STUDY
The left ventricular diastolic dysfunction represents the earliest pre-clinical manifestation of diabetic cardiomyopathy, preceding the systolic dysfunction and being able to evolve to symptomatic heart failure
Accordingly, it is highly recommended to perform early detection and management of myocardial dysfunction in the diabetic population before the development of overt HF.

DESCRIPTION 
Newly diagnosed diabetic patients based on study inclusion and exclusion criteria are selected and explained about the study and enrolled after giving informed consent.
Patients are subjected to routine blood investigations such as fasting lipid profile, HbA1c and 2D Echocardiography.
Then patients with dyslipidaemia and Left Ventricular Diastolic Dysfunction are identified based on the tests.
The collected data will be tabulated and analysed and compared between both the groups. The quantitative data will be summarized in excel sheet and Mean , median, standard deviation will be estimated
In order to know the association between Dyslipidemia and Left Ventricular Diastolic Dysfunction simple (PEARSONS) correlation co efficient will be used.




 
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