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

June 19, 2022 updated by: Toka Hesham, MTI University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Al Kasr Al Aini
      • Cairo, Al Kasr Al Aini, Egypt
        • Recruiting
        • National Institute of Diabetes and Endocrinology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study contains 2 groups each group consists of 30 patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
patients will be treated with DPP4 inhibitor + metformin
Drug: Vildagliptin
observe the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients
control
patients will be treated with metformin without DPP4 inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improve the neurodegeneration and cardiovascular effect in diabetic patients
Time Frame: September 2022
improve the cognition and cardiovascular effect in type 2 diabetic patients
September 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MTI University

Collaborators

National Institute of Diabetes and Endocrinology, Egypt

Investigators

  • Principal Investigator: Toka Hesham, Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

June 19, 2022

First Submitted That Met QC Criteria

June 19, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDEoo281

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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