NCT05347459

Cognitive Protective Effect of Newer Antidiabetic Drugs

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Dapagliflozin	usual and customary doses for type 2 diabetes management
DRUG	Empagliflozin	usual and customary doses for type 2 diabetes management
DRUG	Canagliflozin	usual and customary doses for type 2 diabetes management
DRUG	Sitagliptin	usual and customary doses for type 2 diabetes management
DRUG	Saxagliptin	usual and customary doses for type 2 diabetes management
DRUG	Linagliptin	usual and customary doses for type 2 diabetes management
DRUG	Vildagliptin	usual and customary doses for type 2 diabetes management

Timeline

• Start date: 2022-03-02
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-04-26
• Last updated: 2022-07-26

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study