Effect Of Dapagliflozin On Serum Brain-Derived Neurotrophic Factor (BDNF) Levels In Uncontrolled Type 2 Diabetes Mellitus Patients- A Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Serum BDNF levels
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Serum BDNF levels
Time Frame: At the time of recruitment and at 3 months
Secondary Outcomes
- FBS, PPBS, HbA1c and PHQ-9 Scores(At the time of recruitment and at 3 months)
Investigators
Prasanjit Das
All India Institute of Medical Sciences, Kalyani