Cognitive Protective Effect of Newer Antidiabetic Drugs

Alexandria University

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin; Drug: Linagliptin; Drug: Empagliflozin; Drug: Vildagliptin; Drug: Sitagliptin; Drug: Canagliflozin; Drug: Dapagliflozin

Study type: Observational

Funder types: Other

Identifiers

NCT05347459

DIAB-DRUG-COG-FUN-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

New Antidiabetic

Description:

Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin

Treatment:

Drug: Empagliflozin

Drug: Vildagliptin

Drug: Canagliflozin

Drug: Linagliptin

Drug: Saxagliptin

Drug: Dapagliflozin

Drug: Sitagliptin

Traditional Antidiabetic

Description:

Type 2 diabetic patients treated with metformin

Control

Description:

Healthy non-diabetic patients