Cognitive Protective Effect of Newer Antidiabetic Drugs

NCT ID: NCT05347459

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-02

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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New Antidiabetic

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

Dapagliflozin

Intervention Type DRUG

usual and customary doses for type 2 diabetes management

Empagliflozin

Intervention Type DRUG

usual and customary doses for type 2 diabetes management

Canagliflozin

Intervention Type DRUG

usual and customary doses for type 2 diabetes management

Sitagliptin

Intervention Type DRUG

usual and customary doses for type 2 diabetes management

Saxagliptin

Intervention Type DRUG

usual and customary doses for type 2 diabetes management

Linagliptin

Intervention Type DRUG

usual and customary doses for type 2 diabetes management

Vildagliptin

Intervention Type DRUG

usual and customary doses for type 2 diabetes management

Traditional Antidiabetic

Type 2 diabetic patients treated with metformin

No interventions assigned to this group

Control

Healthy non-diabetic patients

No interventions assigned to this group

Interventions

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Dapagliflozin

usual and customary doses for type 2 diabetes management

Intervention Type DRUG

Empagliflozin

usual and customary doses for type 2 diabetes management

Intervention Type DRUG

Canagliflozin

usual and customary doses for type 2 diabetes management

Intervention Type DRUG

Sitagliptin

usual and customary doses for type 2 diabetes management

Intervention Type DRUG

Saxagliptin

usual and customary doses for type 2 diabetes management

Intervention Type DRUG

Linagliptin

usual and customary doses for type 2 diabetes management

Intervention Type DRUG

Vildagliptin

usual and customary doses for type 2 diabetes management

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed El-Yazbi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed F El-Yazbi, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Pharmacology and Therapeutics, Alexandria University

Labiba El-Khordagui, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Pharmaceutics, Alexandria University

Noha A Hamdy, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Clinical Pharmacy, Alexandria University

Amr El-Feky, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Internal Medicine, Alexandria University

Shams T Osman, BPharm

Role: PRINCIPAL_INVESTIGATOR

Instructor of Clinical Pharmacy, Alexandria University

Locations

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Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shams T Osman, BPharm

Role: CONTACT

+201096900070

Ahmed F El-Yazbi, PhD

Role: CONTACT

+201155881772

Facility Contacts

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Shams T Osman, BPharm

Role: primary

+201096900070

Ahmed F El-Yazbi, PhD

Role: backup

+201155881772

Other Identifiers

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DIAB-DRUG-COG-FUN-1

Identifier Type: -

Identifier Source: org_study_id

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