| 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
|
|
|
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
|
|
|
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. |