Effect Of Dapagliflozin On Serum Brain-Derived Neurotrophic Factor (BDNF) Levels In Uncontrolled Type 2 Diabetes Mellitus Patients- A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum BDNF levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Serum BDNF levels
时间窗: At the time of recruitment and at 3 months
次要结局
- FBS, PPBS, HbA1c and PHQ-9 Scores(At the time of recruitment and at 3 months)
研究者
Prasanjit Das
All India Institute of Medical Sciences, Kalyani