Cognitive Protective Effect of Newer Antidiabetic Drugs

NCT05347459 | Unknown FDA Drug

• 1 other identifier: DIAB-DRUG-COG-FUN-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to:

1. 1.Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria
2. 2.Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients
3. 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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Prevention of decline in cognitive function associated with type 2 diabetes

  Slowed reduction of the Montreal Cognitive Assessment Battery Score

  1 Year

Secondary Outcomes (1)

• Better cognitive performance in the intervention group at baseline

  1 Year

Other Outcomes (1)

• Reduced serum inflammatory markers in intervention group

  1 Year

Study Arms (3)

New Antidiabetic

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

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

Traditional Antidiabetic

Type 2 diabetic patients treated with metformin

Control

Healthy non-diabetic patients

Interventions

Dapagliflozin DRUG

usual and customary doses for type 2 diabetes management

New Antidiabetic

Empagliflozin DRUG

usual and customary doses for type 2 diabetes management

New Antidiabetic

Canagliflozin DRUG

usual and customary doses for type 2 diabetes management

New Antidiabetic

Sitagliptin DRUG

usual and customary doses for type 2 diabetes management

New Antidiabetic

Saxagliptin DRUG

usual and customary doses for type 2 diabetes management

New Antidiabetic

Linagliptin DRUG

usual and customary doses for type 2 diabetes management

New Antidiabetic

Vildagliptin DRUG

usual and customary doses for type 2 diabetes management

New Antidiabetic

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients receiving care in diabetes ambulatory clinics in Alexandria

You may qualify if:

• Type 2 Diabetic Patients
• Age (≥50 Years)
• Ability to understand and cooperate with study procedures

You may not qualify if:

• Diagnosed dementia
• Use of possible or known cognition impairing drugs in the last three months

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; empagliflozin; Canagliflozin; Sitagliptin Phosphate; saxagliptin; Linagliptin; Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Triazoles; Azoles; Pyrazines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinazolines; Nitriles; Pyrrolidines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shams T Osman, BPharm

CONTACT

+201096900070; s-shams.mostafa@alexu.edu.eg

Ahmed F El-Yazbi, PhD

CONTACT

+201155881772; ahmed.fawzy.aly@alexu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: April 26, 2022
• Study Start: March 2, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be come available after publication and remain available indefinitely
• Access Criteria: Anyone who wishes to access the data

Locations

EG (1)