Clinical trial NCT05347459: Cognitive Protective Effect of Newer Antidiabetic Drugs
Official title: Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients receiving care in diabetes ambulatory clinics in Alexandria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevention of decline in cognitive function associated with type 2 diabetes
timeFrame: 1 Year
Secondary outcomes:
measure: Better cognitive performance in the intervention group at baseline
timeFrame: 1 Year
Other outcomes:
measure: Reduced serum inflammatory markers in intervention group
timeFrame: 1 Year
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Professor of Pharmacology and Therapeutics, Alexandria University
name: Ahmed F El-Yazbi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pharmaceutics, Alexandria University
name: Labiba El-Khordagui, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor of Clinical Pharmacy, Alexandria University
name: Noha A Hamdy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor of Internal Medicine, Alexandria University
name: Amr El-Feky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instructor of Clinical Pharmacy, Alexandria University
name: Shams T Osman, BPharm
role: PRINCIPAL_INVESTIGATOR
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