Type 2 Diabetes MellitusNCT05429554
The Effect of Metformin and DPP4 Inhibitors on Cognition and Cardiovascular Protection in Type 2 Diabetic Patients
An observational study of Type 2 Diabetes Mellitus, run by MTI University at 1 site in Egypt.
Trial summary
The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Sep 2022
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study contains 2 groups each group consists of 30 patients
Who may be able to join
- Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
- moderate hypertension.
Who cannot join
- • Diabetic patients who have been currently receiving anti-diabetic agents other than metformin and/or insulin
- Patients with type 1 DM, active liver disease, recent history of cardiovascular disease (acute coronary syndrome, coronary artery intervention, New York Heart Association Class III/IV heart failure, stroke, transient ischemic neurologic event, or new/worsening symptoms of coronary heart disease or cerebrovascular disease), severe peripheral vascular disease, triglyceride levels ≥ 600 mg/dL, history of HIV infection, pancreatitis, malignancy or clinically important hematologic disorder, and an estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease formula) less than 30 mL/min/1.73 m2.
- Moreover, patients with dementia, AD, those were in delirium status during evaluation period, patients with psychotic disease (schizoaffective disorder, etc.)
- Alcohol and substance addiction were not enrolled in the study.
- Also, patients who have any hypersensitivity to metformin or to DPP4 inhibitors were also excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Institute of diabetes and endocrinology
Cairo, Al Kasr Al Aini
Toka Hesham, +01069155142, tokahesham77@gmail.com
About this study
Official title: The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and Cardiovascular Protection in Type 2 Diabetic Patients
The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients
Read the detailed description
This study aims to investigate the effect of daily oral DPP4 inhibitors and oral metformin on neurodegeneration in type 2 diabetic patients.
This study aims to compare between the cardiovascular protective properties of DPP-4 inhibitors and Metformin in type 2 diabetic patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin
- 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.
VildagliptinDrug
observe the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients
| Study group | Role | What they receive |
|---|---|---|
| group 1 | patients will be treated with DPP4 inhibitor + metformin Receives: Drug: Vildagliptin | |
| control | patients will be treated with metformin without DPP4 inhibitor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve the neurodegeneration and cardiovascular effect in diabetic patients
improve the cognition and cardiovascular effect in type 2 diabetic patients
Measured: September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Endocrinology, Egypt
- Responsible party
- Principal investigator, Toka Hesham, MTI University
- Investigators
- Toka Hesham, Principal investigator, Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429554
- Sponsor's protocol ID
- IDEoo281
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and Cardiovascular Protection in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05429554
- Acronym / sponsor ID
- IDEoo281
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Endocrinology, Egypt
- Study start
- Jun 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 23 Jun 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 Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients
Detailed description
This study aims to investigate the effect of daily oral DPP4 inhibitors and oral metformin on neurodegeneration in type 2 diabetic patients.
This study aims to compare between the cardiovascular protective properties of DPP-4 inhibitors and Metformin in type 2 diabetic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Drug: Vildagliptinpatients will be treated with DPP4 inhibitor + metformin |
| control | – | –patients will be treated with metformin without DPP4 inhibitor. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study contains 2 groups each group consists of 30 patients
Key inclusion criteria (2 listed)
- Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
- moderate hypertension.
Key exclusion criteria (5 listed)
- • Diabetic patients who have been currently receiving anti-diabetic agents other than metformin and/or insulin
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 |
|---|---|---|
| Vildagliptinobserve the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients | Drug | group 1 |
Primary outcome
improve the neurodegeneration and cardiovascular effect in diabetic patients
Time frame: September 2022
improve the cognition and cardiovascular effect in type 2 diabetic patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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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.
Toka Hesham principal investigator
Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)
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 Mellitus, run by MTI 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 2 inclusion and 5 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 23 Jun 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 Toka H Elemary (+01069155142, tokahesham77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improve the neurodegeneration and cardiovascular effect in diabetic patients (time frame: September 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2022.