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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429554
• Other study ID #: IDEoo281
• Status: Recruiting
• Start date: June 2022
• Est. completion date: September 2022

Study information

• Verified date: June 2022
• Source: MTI University
• Contact: Toka H Elemary
• Phone: +01069155142
• Email: tokahesham77[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Egypt	National Institute of diabetes and endocrinology	Cairo	Al Kasr Al Aini

Sponsors (2)

Lead Sponsor	Collaborator
MTI University	National Institute of Diabetes and Endocrinology, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improve the neurodegeneration and cardiovascular effect in diabetic patients	improve the cognition and cardiovascular effect in type 2 diabetic patients	September 2022