Type 2 DiabetesNCT05347459
Cognitive Protective Effect of Newer Antidiabetic Drugs
An observational study of Type 2 Diabetes, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dapagliflozin, Empagliflozin and Canagliflozin
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic patients receiving care in diabetes ambulatory clinics in Alexandria
Who may be able to join
- Type 2 Diabetic Patients
- Age (≥50 Years)
- Ability to understand and cooperate with study procedures
Who cannot join
- Diagnosed dementia
- Use of possible or known cognition impairing drugs in the last three months
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria
Shams T Osman, BPharm, +201096900070, s-shams.mostafa@alexu.edu.eg
Ahmed F El-Yazbi, PhD, +201155881772, ahmed.fawzy.aly@alexu.edu.eg
About this study
Official title: Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients
The proposed study aims to:
- Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria
- Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients
- 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
Read the 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:
- Diabetic patients treated with metformin and DPP-4 inhibitors and/or SGLT2 inhibitors
- 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
- Type 2 Diabetes
- Being tested
- Dapagliflozin, Empagliflozin, Canagliflozin, Sitagliptin, Saxagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
usual and customary doses for type 2 diabetes management
EmpagliflozinDrug
usual and customary doses for type 2 diabetes management
CanagliflozinDrug
usual and customary doses for type 2 diabetes management
SitagliptinDrug
usual and customary doses for type 2 diabetes management
SaxagliptinDrug
usual and customary doses for type 2 diabetes management
LinagliptinDrug
usual and customary doses for type 2 diabetes management
VildagliptinDrug
usual and customary doses for type 2 diabetes management
| Study group | Role | What they receive |
|---|---|---|
| New Antidiabetic | Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of decline in cognitive function associated with type 2 diabetes
Slowed reduction of the Montreal Cognitive Assessment Battery Score
Measured: 1 Year
Secondary outcomes (1)
Better cognitive performance in the intervention group at baseline
Higher Montreal Cognitive Assessment Battery Score
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start2 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Yazbi, Alexandria University
- Investigators
- Ahmed F El-Yazbi, PhD, Principal investigator, Professor of Pharmacology and Therapeutics, Alexandria UniversityLabiba El-Khordagui, PhD, Principal investigator, Professor of Pharmaceutics, Alexandria UniversityNoha A Hamdy, PhD, Principal investigator, Assistant Professor of Clinical Pharmacy, Alexandria UniversityAmr El-Feky, MD, Principal investigator, Assistant Professor of Internal Medicine, Alexandria UniversityShams T Osman, BPharm, Principal investigator, Instructor of Clinical Pharmacy, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347459
- Sponsor's protocol ID
- DIAB-DRUG-COG-FUN-1
- Status last verified
- Jul 2022
- First submitted
- 20 Jan 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication a link will be provided for a data repository folder
Publications
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.
PubMed 40677108
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients
- ClinicalTrials.gov ID
- NCT05347459
- Acronym / sponsor ID
- DIAB-DRUG-COG-FUN-1
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to:
- Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria
- Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients
- 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
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:
- Diabetic patients treated with metformin and DPP-4 inhibitors and/or SGLT2 inhibitors
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New Antidiabetic | – | Drug: Dapagliflozin, Drug: Empagliflozin, Drug: Canagliflozin, Drug: Sitagliptin, Drug: Saxagliptin, Drug: Linagliptin, Drug: VildagliptinType 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients receiving care in diabetes ambulatory clinics in Alexandria
Key inclusion criteria (3 listed)
- Type 2 Diabetic Patients
- Age (≥50 Years)
- Ability to understand and cooperate with study procedures
Key exclusion criteria (2 listed)
- Diagnosed dementia
- Use of possible or known cognition impairing drugs in the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozinusual and customary doses for type 2 diabetes management | Drug | New Antidiabetic |
| Empagliflozinusual and customary doses for type 2 diabetes management | Drug | New Antidiabetic |
| Canagliflozinusual and customary doses for type 2 diabetes management | Drug | New Antidiabetic |
| Sitagliptinusual and customary doses for type 2 diabetes management | Drug | New Antidiabetic |
| Saxagliptinusual and customary doses for type 2 diabetes management | Drug | New Antidiabetic |
| Linagliptinusual and customary doses for type 2 diabetes management | Drug | New Antidiabetic |
| Vildagliptinusual and customary doses for type 2 diabetes management | Drug | New Antidiabetic |
Primary outcome
Prevention of decline in cognitive function associated with type 2 diabetes
Time frame: 1 Year
Slowed reduction of the Montreal Cognitive Assessment Battery Score
1 secondary outcome
Better cognitive performance in the intervention group at baseline
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 40677108Hakim 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.
- Individual participant dataSharing planned: Yes. After publication a link will be provided for a data repository folder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed F El-Yazbi, PhD principal investigator
Professor of Pharmacology and Therapeutics, Alexandria University
Labiba El-Khordagui, PhD principal investigator
Professor of Pharmaceutics, Alexandria University
Noha A Hamdy, PhD principal investigator
Assistant Professor of Clinical Pharmacy, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shams T Osman, BPharm (+201096900070, s-shams.mostafa@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of decline in cognitive function associated with type 2 diabetes (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.