The Effect of Metformin and DPP4 Inhibitors on Cognition and Cardiovascular Protection in Type 2 Diabetic Patients

NCT ID: NCT05429554

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-09-30

Brief Summary

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The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients

Detailed Description

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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

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

patients will be treated with DPP4 inhibitor + metformin

Vildagliptin

Intervention Type DRUG

observe the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients

control

patients will be treated with metformin without DPP4 inhibitor.

No interventions assigned to this group

Interventions

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Vildagliptin

observe the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
* moderate hypertension.

Exclusion Criteria

* • 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Endocrinology, Egypt

UNKNOWN

Sponsor Role collaborator

MTI University

OTHER

Sponsor Role lead

Responsible Party

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Toka Hesham

Teaching assistant of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Toka Hesham

Role: PRINCIPAL_INVESTIGATOR

Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)

Locations

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National Institute of diabetes and endocrinology

Cairo, Al Kasr Al Aini, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Toka H Elemary

Role: CONTACT

+01069155142

Dalia Zaafar

Role: CONTACT

+01117922833

Facility Contacts

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Toka Hesham

Role: primary

+01069155142

Other Identifiers

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IDEoo281

Identifier Type: -

Identifier Source: org_study_id

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