Cognitive Protective Effect of Newer Antidiabetic Drugs

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347459
• Other study ID #: DIAB-DRUG-COG-FUN-1
• Status: Recruiting
• Start date: March 2, 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Alexandria University
• Contact: Shams T Osman, BPharm
• Phone: +201096900070
• Email: s-shams.mostafa[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
usual and customary doses for type 2 diabetes management
• Empagliflozin
usual and customary doses for type 2 diabetes management
• Canagliflozin
usual and customary doses for type 2 diabetes management
• Sitagliptin
usual and customary doses for type 2 diabetes management
• Saxagliptin
usual and customary doses for type 2 diabetes management
• Linagliptin
usual and customary doses for type 2 diabetes management
• Vildagliptin
usual and customary doses for type 2 diabetes management

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduced serum inflammatory markers in intervention group		1 Year
Primary	Prevention of decline in cognitive function associated with type 2 diabetes	Slowed reduction of the Montreal Cognitive Assessment Battery Score	1 Year
Secondary	Better cognitive performance in the intervention group at baseline	Higher Montreal Cognitive Assessment Battery Score	1 Year