Cognitive Protective Effect of Newer Antidiabetic Drugs

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dapagliflozin; Drug: Empagliflozin; Drug: Canagliflozin; Drug: Sitagliptin; Drug: Saxagliptin; Drug: Linagliptin; Drug: Vildagliptin

• Registration Number: NCT05347459
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-20
• Study Start: 2022-03-02
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-24
• Last Update Posted: 2022-07-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New Antidiabetic	Dapagliflozin	Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
New Antidiabetic	Empagliflozin	Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
New Antidiabetic	Canagliflozin	Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
New Antidiabetic	Sitagliptin	Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
New Antidiabetic	Saxagliptin	Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
New Antidiabetic	Linagliptin	Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin
New Antidiabetic	Vildagliptin	Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin

Primary Outcome Measures

Name	Time	Method
Prevention of decline in cognitive function associated with type 2 diabetes	1 Year	Slowed reduction of the Montreal Cognitive Assessment Battery Score

Secondary Outcome Measures

Name	Time	Method
Better cognitive performance in the intervention group at baseline	1 Year	Higher Montreal Cognitive Assessment Battery Score

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt