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

Overview

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

Full Title of Study: “The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and Cardiovascular Protection in Type 2 Diabetic Patients”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: September 2022

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.

Interventions

• Drug: Vildagliptin
  • observe the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients

Arms, Groups and Cohorts

• group 1
  • patients will be treated with DPP4 inhibitor + metformin
• control
  • patients will be treated with metformin without DPP4 inhibitor.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • MTI University
• Collaborator
  • National Institute of Diabetes and Endocrinology, Egypt
• Provider of Information About this Clinical Study
  • Principal Investigator: Toka Hesham, Teaching assistant of Clinical Pharmacy – MTI University
• Overall Official(s)
  • Toka Hesham, Principal Investigator, Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)
• Overall Contact(s)
  • Toka H Elemary, +01069155142, tokahesham77@gmail.com