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

Sponsor

MTI University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05429554

Collaborator

National Institute of Diabetes and Endocrinology, Egypt (Other)

Enrollment

Location

Anticipated Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Vildagliptin

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

improve the neurodegeneration and cardiovascular effect in diabetic patients [September 2022]
improve the cognition and cardiovascular effect in type 2 diabetic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of diabetes and endocrinology	Cairo	Al Kasr Al Aini	Egypt

Sponsors and Collaborators

MTI University
National Institute of Diabetes and Endocrinology, Egypt

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Toka Hesham, Teaching assistant of Clinical Pharmacy, MTI University

ClinicalTrials.gov Identifier:

NCT05429554

Other Study ID Numbers:

IDEoo281

First Posted:

Jun 23, 2022

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Vildagliptin

Study Results

No Results Posted as of Jun 23, 2022