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CTRI Number  CTRI/2024/04/065339 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Dapagliflozin on Unconscious functions of the heart in Diabetic Patients. 
Scientific Title of Study   An Open Label Randomized Controlled Trial to evaluate the effect of Dapagliflozin on Cardiac autonomic functions in T2DM patients 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Keerthi Annepu 
Designation  junior resident 
Affiliation  Jawaharlal Nehru Medical College, AMU 
Address  Neurophysiology Lab, Department of Physiology, JNMC, AMU, Aligarh , Uttar Pradesh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8978160381  
Fax    
Email  annepukeerthi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ahmad Faraz 
Designation  Assistant Professor 
Affiliation  Jawaharlal Nehru Medical College, AMU 
Address  Room No 12, Department of Physiology, JNMC, AMU, Aligarh , Uttar Pradesh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9997625257  
Fax    
Email  afaraz83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Krishna Keerthi Annepu 
Designation  junior resident 
Affiliation  Jawaharlal Nehru Medical College, AMU 
Address  Neurophysiology lab, Department of Physiology, JNMC, AMU, Aligarh , Uttar Pradesh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8978160381  
Fax    
Email  annepukeerthi@gmail.com  
 
Source of Monetary or Material Support  
J.N Medical College, Aligarh Muslim University, Aligarh 
 
Primary Sponsor  
Name  Krishna Keerthi Annepu 
Address  JNMC, AMU, Aligarh, Uttar Pradesh 
Type of Sponsor  Government medical college 
 
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 Krishna Keerthi Annepu  J.N Medical College and Hospital  Neurophysiology lab, Department of Physiology, J.N Medical College, Aligarh muslim University, Aligarh
Aligarh
UTTAR PRADESH 
8978160381

annepukeerthi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, AMU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  standard of care antidiabetics agent. (Vildagliptins and Metformin)  Vildagliptin 50 mg twice a day Metformin 500 mg twice a day for 6 months 
Intervention  Tab Dapagliflozin  Dapagliflozin 10 mg once a day for 6 months Standard of care (Vildagliptin 50 mg twice a day Metformin 500 mg twice a day) for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Type 2 DM patients
2. Patients who are willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Type 1 DM
2. Hypertensives
3. heart failure
4. valvular disease
5. COPD
6. Renal failure
• Patients on drugs like beta-receptor blockers, antihypertensives, sedatives
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The study will evaluate whether taking dapagliflozin will reduce the risk of cardiac autonomic dysfunction compared to a control group among patients with type 2 diabetes mellitus (T2DM).  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
The study will evaluate the effect of SGLT2 inhibitors on BMI, lipid profile in patients of T2DM.  6 Months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/04/2024 
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 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  

Background: Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired glucose regulation. Individuals with T2DM are at an increased risk of developing cardiovascular complications, including autonomic dysfunction, which affects the regulation of heart rate and blood pressure. SGLT2 inhibitors, such as Dapagliflozin, have emerged as a promising class of medications for managing T2DM by promoting glycosuria and improving glycemic control. Additionally, there is evidence suggesting that SGLT2 inhibitors may have beneficial effects on cardiovascular outcomes beyond glycemic control, including improvements in cardiac autonomic function.

Rationale: The rationale behind conducting an open-label randomized controlled trial to evaluate the effect of Dapagliflozin on cardiac autonomic functions in T2DM patients is multifaceted. Firstly, understanding the influence of SGLT2 inhibitors on cardiac autonomic function could provide valuable insights into their cardiovascular benefits beyond glycemic control. Secondly, elucidating the effects of Dapagliflozin on cardiac autonomic function may contribute to optimizing the management of T2DM and reducing the burden of cardiovascular complications in this patient population. Thirdly, cardiac autonomic dysfunction is a significant predictor of adverse cardiovascular events and mortality in T2DM patients, making it a clinically relevant endpoint to assess the efficacy of Dapagliflozin. Overall, this trial aims to address the gap in knowledge regarding the potential cardioprotective effects of SGLT2 inhibitors by evaluating their impact on cardiac autonomic function in individuals with T2DM.

 
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