Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevention of decline in cognitive function associated with type 2 diabetes
研究概览
简要总结
The proposed study aims to:
- Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria
- Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients
- Undertake a network analysis to elucidate the potential pathways linking the observed protective effects, if any, with the observed changes in inflammatory or metabolic parameters
详细描述
The investigators propose to profile diabetic patients taking SGLT2 inhibitors and DPP-4 inhibitors using different parameters and compare them to others on more traditional anti-diabetic therapy. Regression and comparative statistics will be used to determine whether the targeted drug classes offer a benefit in terms of cognitive function. If a trend (or correlation) is determined, a bioinformatic approach will be adopted to perform a network analysis including the targets of these drug classes and pathways showing in datasets of the inflammatory or metabolic parameters altered by the drug. This network analysis is intended to provide further mechanistic insight into the pathways involved in the observed drug action.
The patients targeted will be divided into the following groups:
- Diabetic patients treated with metformin and DPP-4 inhibitors and/or SGLT2 inhibitors
- Diabetic patients treated with metformin only
This will be in addition to a group of healthy non-diabetic controls to serve as a baseline reference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetic Patients
- •Age (≥50 Years)
- •Ability to understand and cooperate with study procedures
排除标准
- •Diagnosed dementia
- •Use of possible or known cognition impairing drugs in the last three months
研究组 & 干预措施
New Antidiabetic
Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
干预措施: Dapagliflozin (Drug)
New Antidiabetic
Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
干预措施: Empagliflozin (Drug)
New Antidiabetic
Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
干预措施: Canagliflozin (Drug)
New Antidiabetic
Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
干预措施: Sitagliptin (Drug)
New Antidiabetic
Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
干预措施: Saxagliptin (Drug)
New Antidiabetic
Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
干预措施: Linagliptin (Drug)
New Antidiabetic
Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Prevention of decline in cognitive function associated with type 2 diabetes
时间窗: 1 Year
Slowed reduction of the Montreal Cognitive Assessment Battery Score
次要结局
- Better cognitive performance in the intervention group at baseline(1 Year)
研究者
Ahmed El-Yazbi
Professor
Alexandria University
