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

NCT05429554 | Unknown DMC FDA Drug

• 1 other identifier: IDEoo281
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• improve the neurodegeneration and cardiovascular effect in diabetic patients

  improve the cognition and cardiovascular effect in type 2 diabetic patients

  September 2022

Study Arms (2)

group 1

patients will be treated with DPP4 inhibitor + metformin

Drug: Vildagliptin

control

patients will be treated with metformin without DPP4 inhibitor.

Interventions

Vildagliptin DRUG

observe the effect of vildagliptin on cognitive function and cardiovascular in diabetic patients

group 1

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study contains 2 groups each group consists of 30 patients

You may qualify if:

• Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
• moderate hypertension.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTI University: lead
• National Institute of Diabetes and Endocrinology, Egypt: collaborator

Study Sites (1)

National Institute of diabetes and endocrinology

Cairo, Al Kasr Al Aini, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Toka Hesham

  Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toka H Elemary

CONTACT

+01069155142; tokahesham77@gmail.com

Dalia Zaafar

CONTACT

+01117922833; dalia.zaffar@pharm.mti.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant of Clinical Pharmacy

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 23, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

EG (1)