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

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Vildagliptin

• Registration Number: NCT05429554
• Lead Sponsor: MTI University

Brief Summary

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 Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-19
• Study First Submitted QC: 2022-06-19
• Last Update Submitted: 2022-06-19
• Study First Posted: 2022-06-23
• Last Update Posted: 2022-06-23
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	Vildagliptin	patients will be treated with DPP4 inhibitor + metformin

Primary Outcome Measures

Name	Time	Method
improve the neurodegeneration and cardiovascular effect in diabetic patients	September 2022	improve the cognition and cardiovascular effect in type 2 diabetic patients

Trial Locations

Locations (1)

National Institute of diabetes and endocrinology; 🇪🇬 Cairo, Al Kasr Al Aini, Egypt