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临床试验/NCT05347459
NCT05347459Unknown不适用

Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients

Alexandria University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月2日最近更新:
适应症
干预措施

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:

  1. Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria
  2. Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients
  3. 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:

  1. Diabetic patients treated with metformin and DPP-4 inhibitors and/or SGLT2 inhibitors
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed El-Yazbi

Professor

Alexandria University

研究点 (1)

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