The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- MCI
研究概览
简要总结
The study aims to investigate the effects of DPP-4 Is+ metformin versus SGLT2 Is + metformin on the risk of cognitive decline and depression in patients with T2DM.
详细描述
Older people suffering from Type 2 Diabetes Mellitus possess a major risk for age related cognitive dysfunction and dementia, mainly due to vascular complications.
SGLT2 inhibitors and DPP4 inhibitors are antidiabetic medications, have shown promise not only in glycemic control but also in potentially mitigating cognitive decline and depressive symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study participants should meet the following inclusion criteria:
- •T2DM adult subjects (>55 years old) will be eligible to participate.
- •Patients should be taking SGLT2Is+metformin or DDP4Is + metformin for at least 1 year to be eligible.
排除标准
- •1- Those with type1 diabetes or ketoacidosis, insulin therapy, end organ failure as chronic renal failure, liver, and heart failure, previous history of pancreatitis, history of Alzheimer's disease or any brain insult, and finally pregnant or lactating females will be excluded from the study.
研究组 & 干预措施
SGLT2 I Group
T2DM patients given SGLT2 Is + metformin added to standard of care
干预措施: SGLT2 Is+METFORMIN (Drug)
DPP4I group
T2DM patients given DPP4Is + metformin added to standard of care
干预措施: DPP4 Is+metformin (Drug)
Control group
T2DM patients given conventional therapy only
干预措施: Control group (Drug)
结局指标
主要结局
MCI
时间窗: Day 1
Changes in Montreal Cognitive Assessment (MoCA) score
Depression
时间窗: Day 1
Changes in Patient Health Questionnaire-9 (PHQ-9) score
次要结局
未报告次要终点
研究者
Asmaa Abdelfattah Elsayed
Lecturer of clinical pharmacy
Beni-Suef University