Cognitive Protective Effect of Newer Antidiabetic Drugs

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Empagliflozin
* Drug: Canagliflozin
* Drug: Sitagliptin
* Drug: Saxagliptin
* Drug: Linagliptin
* Drug: Vildagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetic Patients Age (≥50 Years) Ability to understand and cooperate with study procedures Exclusion Criteria: Diagnosed dementia Use of possible or known cognition impairing drugs in the last three months

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New Antidiabetic<br>Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin | Drug: Dapagliflozin<br>* usual and customary doses for type 2 diabetes management<br>Drug: Empagliflozin<br>* usual and customary doses for type 2 diabetes management<br>Drug: Canagliflozin<br>* usual and customary doses for type 2 diabetes management<br>Drug: Sitagliptin<br>* usual and customary doses for type 2 diabetes management<br>Drug: Saxagliptin<br>* usual and customary doses for type 2 diabetes management<br>Drug: Linagliptin<br>* usual and customary doses for type 2 diabetes management<br>Drug: Vildagliptin<br>* usual and customary doses for type 2 diabetes management<br>|
| Traditional Antidiabetic<br>Type 2 diabetic patients treated with metformin | |
| Control<br>Healthy non-diabetic patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of decline in cognitive function associated with type 2 diabetes | Slowed reduction of the Montreal Cognitive Assessment Battery Score | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Better cognitive performance in the intervention group at baseline | Higher Montreal Cognitive Assessment Battery Score | 1 Year |