| CTRI Number |
CTRI/2025/07/090876 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Dapagliflozin on Brain Health in People with Uncontrolled Type 2 Diabetes |
|
Scientific Title of Study
|
Effect Of Dapagliflozin On Serum Brain-Derived Neurotrophic Factor (BDNF) Levels In Uncontrolled Type 2 Diabetes Mellitus Patients- A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanjit Das |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Kalyani |
| Address |
House No. 37, Ward No. 24, Near Geeta General Store, Vivekananda Colony, Prothrapur, South Andaman, Andaman and Nicobar Islands - 744105
Andamans
ANDAMAN & NICOBAR ISLANDS
744105
India |
| Phone |
9476084509 |
| Fax |
|
| Email |
docprasanjitdas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karuna Sree Podila |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Kalyani |
| Address |
Department of Pharmacology, Academic Block 1, All India Institute of Medical Sciences, Kalyani, Near NH 34 connector, Basantapur, Nadia district, West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9494554545 |
| Fax |
|
| Email |
karunasree.pharma@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prasanjit Das |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Kalyani |
| Address |
House No. 37, Ward No. 24, Near Geeta General Store, Vivekananda Colony, Prothrapur, South Andaman, Andaman and Nicobar Islands - 744105
Andamans
ANDAMAN & NICOBAR ISLANDS
744105
India |
| Phone |
9476084509 |
| Fax |
|
| Email |
docprasanjitdas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
Prasanjit Das |
| Address |
House No. 37, Ward No. 24, Near Geeta General Store, Vivekananda Colony, Prothrapur, South Andaman, Andaman and Nicobar Islands - 744105 |
| Type of Sponsor |
Other [Investigator himself] |
|
|
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 Prasanjit Das |
All India Institute of Medical Sciences, Kalyani |
Room No 704, Department of Pharmacology, Academic Block 1, Near NH 34 Connector, Basantapur, Saguna, Kalyani, Nadia District, West Bengal, 741245
Nadia
WEST BENGAL |
9476084509
docprasanjitdas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Uncontrolled T2DM patients aged more than or equal to 18 years with standard antidiabetic treatment [Metformin with any of the Dipeptidyl peptidase 4 inhibitor (DPP4i)] who are started on Dapagliflozin or a Sulfonylurea (SU) group of drugs like Glimepiride for DM control |
|
| ExclusionCriteria |
| Details |
a) Type 1 diabetes mellitus (T1DM) patients.
b) T2DM patients on Basal Insulin + Metformin + Another Oral Antidiabetic drug or patients on triple Oral Antidiabetic drug combination at the time of recruitment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum BDNF levels |
At the time of recruitment and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FBS, PPBS, HbA1c and PHQ-9 Scores |
At the time of recruitment and at 3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective observational study will evaluate the effect of dapagliflozin on serum brain-derived neurotrophic factor (BDNF) levels in patients with uncontrolled type 2 diabetes mellitus. BDNF, a protein essential for brain health, is often altered in diabetes, potentially affecting cognitive functions. Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor used for glycemic control, may have a role in modulating BDNF levels. Eligible patients initiated on dapagliflozin will be followed to assess changes in serum BDNF and glycemic parameters over the study period. The findings may provide insights into the potential neuroprotective effects of dapagliflozin in diabetes management. |