Cognitive Protective Effect of Newer Antidiabetic Drugs

• Sponsor: Alexandria University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05347459
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Dapagliflozin; Drug: Empagliflozin; Drug: Canagliflozin; Drug: Sitagliptin; Drug: Saxagliptin; Drug: Linagliptin; Drug: Vildagliptin

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients
• Actual Study Start Date: Mar 2, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
New Antidiabetic Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin	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
Traditional Antidiabetic Type 2 diabetic patients treated with metformin
Control Healthy non-diabetic patients

Outcome Measures

Primary Outcome Measures

1. Prevention of decline in cognitive function associated with type 2 diabetes [1 Year]

   Slowed reduction of the Montreal Cognitive Assessment Battery Score

Secondary Outcome Measures

1. Better cognitive performance in the intervention group at baseline [1 Year]

   Higher Montreal Cognitive Assessment Battery Score

Other Outcome Measures

1. Reduced serum inflammatory markers in intervention group [1 Year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria University	Alexandria		Egypt

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Ahmed F El-Yazbi, PhD, Professor of Pharmacology and Therapeutics, Alexandria University
• Principal Investigator: Labiba El-Khordagui, PhD, Professor of Pharmaceutics, Alexandria University
• Principal Investigator: Noha A Hamdy, PhD, Assistant Professor of Clinical Pharmacy, Alexandria University
• Principal Investigator: Amr El-Feky, MD, Assistant Professor of Internal Medicine, Alexandria University
• Principal Investigator: Shams T Osman, BPharm, Instructor of Clinical Pharmacy, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed El-Yazbi, Professor, Alexandria University
• ClinicalTrials.gov Identifier: NCT05347459
• Other Study ID Numbers: DIAB-DRUG-COG-FUN-1
• First Posted: Apr 26, 2022
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Sitagliptin Phosphate; Dapagliflozin; Empagliflozin; Linagliptin; Vildagliptin; Saxagliptin; Canagliflozin

Study Results

No Results Posted as of Jul 26, 2022