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The proposed study aims to:
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:
This will be in addition to a group of healthy non-diabetic controls to serve as a baseline reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Antidiabetic | Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin |
| |
| Traditional Antidiabetic | Type 2 diabetic patients treated with metformin | ||
| Control | Healthy non-diabetic patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | usual and customary doses for type 2 diabetes management |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of decline in cognitive function associated with type 2 diabetes | Slowed reduction of the Montreal Cognitive Assessment Battery Score | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Better cognitive performance in the intervention group at baseline | Higher Montreal Cognitive Assessment Battery Score | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced serum inflammatory markers in intervention group | 1 Year |
Inclusion Criteria:
Exclusion Criteria:
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Diabetic patients receiving care in diabetes ambulatory clinics in Alexandria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Recruiting | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40677108 | Derived | Hakim MA, Sanni A, Osman ST, Hamdy NA, Purba WT, Bhuiyan MMAA, Onigbinde S, El-Khordagui LK, El-Yazbi A, Mechref Y. Serum Proteome Profiling of Diabetic Patients Treated With DPP4 and SGLT2 Inhibitors Shows Improved Cognitive and Cardiovascular Functions. Proteomics. 2025 Jul;25(14):e70000. doi: 10.1002/pmic.70000. Epub 2025 Jul 17. |
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After publication a link will be provided for a data repository folder
Data will be come available after publication and remain available indefinitely
Anyone who wishes to access the data
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C570240 | empagliflozin |
| D000068896 | Canagliflozin |
| D000068900 | Sitagliptin Phosphate |
| C502994 | saxagliptin |
| D000069476 | Linagliptin |
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Blood samples
| Empagliflozin |
| Drug |
usual and customary doses for type 2 diabetes management |
|
| Canagliflozin | Drug | usual and customary doses for type 2 diabetes management |
|
| Sitagliptin | Drug | usual and customary doses for type 2 diabetes management |
|
| Saxagliptin | Drug | usual and customary doses for type 2 diabetes management |
|
| Linagliptin | Drug | usual and customary doses for type 2 diabetes management |
|
| Vildagliptin | Drug | usual and customary doses for type 2 diabetes management |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014230 | Triazoles |
| D001393 | Azoles |
| D011719 | Pyrazines |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011799 | Quinazolines |
| D009570 | Nitriles |
| D011759 | Pyrrolidines |